Reported Jan 27, 2021 · Terminated
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation…
Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone
- Item Number 233500004 - Product Usageindicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone
- Lot codes and dates
- Item233500004
- Lot
516349545167
- UDI
(01)0088030483464(10)516349(01)00880304834644(11)190208(10)545167
- Amount recalled
- 174 systems
Where it was sold
- Nationwide
Why it was recalled
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
This product could cause temporary or reversible health problems — stop using it.
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