Device product
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Z-0788-2013
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 64028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 Units
- Official record key
device-enforcement:Z-0788-2013
Official wording
Reason: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Code information: Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
Distribution pattern: Distributed in the states of TN, FL, VA, WA and NV.
Derived failure modes
-
Unknown
Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.