Reported May 6, 2015 · Terminated
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Zimmer GmbH
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: Zimmer Gmbh · Sulzer Allee 8 · Winterthur · N/A
Is this the product you have?
- Anatomical
- Shoulder Handle for Rasp Item01.04233.000 Used during total joint arthroplasty of the shoulder
- Lot codes and dates
- Lot Number(s)13870129 & 13878179
- Amount recalled
- 30 units
Where it was sold
Why it was recalled
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
This product could cause temporary or reversible health problems — stop using it.
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