Reported Aug 8, 2012 · Terminated
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF…
Zimmer Inc.
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 Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
- Lot codes and dates
- Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
- Amount recalled
- 65 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
This product could cause temporary or reversible health problems — stop using it.
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