Reported Jun 10, 2015 · Terminated
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
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. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
- Lot codes and dates
- Item No. 00-5901-032-00
- Lots
5657284556574197565745345657477556575838565732495657419856574535565758275657583956573282565743255657453656575828565758405657328356574326565746045657582956576089565732845657432756574605565758305657609056573285565743285657460656575831565760915657413056574329565746075657583256576421565741355657453056574608565758335657642956574136565745315657461756575836565764315657413756574532565747145657583756576544565741965657453356574774
- Amount recalled
- 1,689
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
Why it was recalled
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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