Reported May 4, 2016 · Terminated
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of…
Synthes (USA) Products LLC
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: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
- Lot codes and dates
- Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
This product could cause temporary or reversible health problems — stop using it.
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