Reported Mar 20, 2013 · Terminated
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External…
Synthes USA HQ, 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: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Large Combination Clamp/Large External Fixation System, Part Number 390.005
- Product UsageSynthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation
- Lot codes and dates
Lot Numbers 660207065823336581191and 6581193
- Amount recalled
- 136
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
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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