FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- Recall number
- Z-2966-2018
- Recalling firm
- Exactech, Inc.
- Product
- Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- Status
- Terminated
- Initiated
- 2018-07-13
- Posted
- not on file
- Terminated
- 2021-04-22
- Reason
- 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
- Employee error
- Action
- The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.
- Quantity
- 7 units
- Distribution
- CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
- Lot, serial or model codes
- GTIN10885862525629, Lot Number 098299003
- 510(k) numbers
- ["K152217"]
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28