Reported Jun 17, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended…
Biomet
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: Biomet · 6303 Blue Lagoon Dr Ste 100 · Miami, FL · 33126-6023
Is this the product you have?
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT
- Item Number110017737 -
- Product UsageIntended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process
- Lot codes and dates
- Lot Number054380 (01)00887868134845(17)251111(10)054380
- Amount recalled
- 15 OUS
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
Why it was recalled
Distributed to the field without having completed design history files or design transfer activities
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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