Recalls / —
—#166109
Product
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- 510(k) numbers
- K152217
- Affected lot / code info
- GTIN10885862525629, Lot Number 098299003
Why it was recalled
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
Root cause (FDA determination)
Employee error
Action the firm took
The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.
Recalling firm
- Firm
- Exactech, Inc.
- Address
- 2320 NW 66th Ct, Gainesville, Florida 32653-1630
Distribution
- Distribution pattern
- CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
Timeline
- Recall initiated
- 2018-07-13
- Terminated
- 2021-04-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #166109. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.