Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes (USA) Products LLC
- Reason for Recall:
- The label on the outer packaging does not match the product inside and intended use of the device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.
Product Codes/Lot Numbers:
Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
Distribution:
Distributed in: US, OH, ND
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1392-2016
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