Reported May 27, 2015 · Terminated
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 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.
- Lot codes and dates
- Ref #:Lot
- Number - 5096-4615
MMR8M85096-4615:MMRLYD5096-4615:MNAYT75096-5015:MMPO6K5096-5015:MMRWOJ5096-5015:MNADVA5096-5815:MNA40L5096-5820:MMR6HX5096-5825:MMRLD75096-6225:MMPWO55096-6225:MMRM2Y5096-6625:MMNM07
- Amount recalled
- 1,147 in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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