Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:MNADVA; 5096-5815:MNA40L; 5096-5820:MMR6HX; 5096-5825:MMRLD7; 5096-6225:MMPWO5; 5096-6225:MMRM2Y; 5096-6625:MMNM07
- 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:
- Stryker Howmedica Osteonics Corp.
- Reason for Recall:
- The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
Product Codes/Lot Numbers:
Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:MNADVA; 5096-5815:MNA40L; 5096-5820:MMR6HX; 5096-5825:MMRLD7; 5096-6225:MMPWO5; 5096-6225:MMRM2Y; 5096-6625:MMNM07
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1633-2015
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A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.