FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
- Recall number
- Z-2250-2021
- Recalling firm
- Exactech, Inc.
- Product
- Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
- Status
- Completed
- Initiated
- 2021-06-29
- Posted
- 2021-08-12
- Terminated
- not on file
- Reason
- Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
- Root cause
- Under Investigation by firm
- Action
- The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021.
- Quantity
- 29 devices
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 6465589-6465618; 6465641
- 510(k) numbers
- ["K050398"]
- PMA numbers
- not on file
- Product code
- LZO
- 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