FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
- Recall number
- Z-0459-2021
- Recalling firm
- Exactech, Inc.
- Product
- Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
- Status
- Terminated
- Initiated
- 2020-10-06
- Posted
- not on file
- Terminated
- 2023-11-13
- Reason
- The product may be mislabeled.
- Root cause
- Packaging process control
- Action
- Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.
- Quantity
- 69 devices
- Distribution
- US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom
- Lot, serial or model codes
- Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318
- 510(k) numbers
- ["K113309"]
- PMA numbers
- not on file
- Product code
- KWS
- 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