Medtronic Sofamor Danek USA

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

The incorrect product labeling was applied to the product indicating the wrong size of product.

Incorrect Laser Marking - Solera Awl Tip Tap

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Engraving on implants may not match what is listed on the pouch labels.

Engraving on implants may not match what is listed on the pouch labels.

Product is impacted by a thread profile defect due to a manufacturing issue.

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

Nonconforming product; length of the product measured shorter than the labeled length.

The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.

Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.

Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.