Reported Sep 4, 2013 · Terminated
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH…
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?
- ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178
- MM LENGTH STERILE RX ONLY Product UsageUsage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures
- includingComminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions
- Lot codes and dates
Item No. 47-2358-107-11Lots 6180330761969598and 62084127 Item No. 47-2358-107-15Lot 61825319
- Amount recalled
- 11 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.
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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