Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
This recall has been terminated (originally issued October 6, 2020).
- Company
- Exactech, Inc.
- Recall Initiated
- October 6, 2020
- Terminated
- November 13, 2023
- Recall Number
- Z-0460-2021
- Quantity
- 40 devices
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The product may be mislabeled.
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 / Code Info
Catalog 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032
Root Cause
Packaging process control
Action Taken
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.