Device product
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
Z-0460-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 86630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 devices
- Official record key
device-enforcement:Z-0460-2021
Official wording
Reason: The product may be mislabeled.
Code information: 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
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
mislabeled