Reported Aug 21, 2019 · Terminated
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS…
BioPro, 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: BioPro, Inc. · 2929 Lapeer Rd · Port Huron, MI · 48060-2558
Is this the product you have?
- K-Wire HBS Sterile
- Item Number 19688 - Product UsageAccessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
- Lot codes and dates
- UDI M209196880 Lot Number - 122572 MFD Date - 4/23/2019
- Amount recalled
- 17 units
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
Why it was recalled
Manufacturing flaw in the sterile barrier system
This product could cause temporary or reversible health problems — stop using it.
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