Reported Apr 17, 2013 · Terminated
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive,…
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 Drive · Mahwah, NJ · 07430
Is this the product you have?
- Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.
- Lot codes and dates
100 of 100 products
Products covered by this recall Model / number Product as published 6541-4-805.Lot Numbers: RD4V204 — RD5V234 — RD5V235 — RD5V235A — RD5V235Y — RD5V236 — RD5V236A — RD5V237 — RD6A009 — RD6A010 — RD6A011 — RD6A011P — RD6A012 — RD6A051 — RD6A052 — RD6A053 — RD6A053M — RD6A053T — RD6A061 — RD6A061A - Amount recalled
- 871 units
Where it was sold
- Nationwide
Why it was recalled
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
This product could cause temporary or reversible health problems — stop using it.
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