Reported May 8, 2024 · Ongoing
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and…
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?
- ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of
- osteotomies and fractures Item Number00-2357-018-10
- Lot codes and dates
- GTIN00889024055933
- Lot NumbersLot Number
100 of 100 codes
642994566429945864299460642994616429946364299529642995306429954464299545644066296440663064406632644066336440664164452257644522586445225964452260644522616445226264452263645682576456825864568259646895566468955864689560646895626468956664689568646895706468957564689576646895776468958264689583646895846468958564689586646895876469770364697704647633526476335364763354647633556476335664763357647633586476335964763360647633616476336264763363647633646476336564777233647772346477723564777236
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
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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