Reported Nov 20, 2019 · Terminated
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the…
Exactech, 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: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- 2.4mm x 2.5 Fluted Pin Pouch
- Catalog Number351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage
- Total Ankle System - Product UsageTo assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 351-90-22— — 10885862567529UDI Number: 10885862567529 — Expiration Date: 08/28/2028 — Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273) — Packaging Lots Numbers (49079322, 49079321) — Manufacturing Lot Number:19030412 - Amount recalled
- 9 units
Where it was sold
Why it was recalled
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
This product could cause temporary or reversible health problems — stop using it.
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