Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER — Class II medical device recall Z-0788-2013
Terminated recall by Exactech, Inc., reported 2013-02-13, distributed in FL, NV, TN, VA, WA. Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Conn
| Recall number | Z-0788-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2013-02-05 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-12-24 |
| Distributed | FL, NV, TN, VA, WA |
| Quantity | 26 units |
| Reason classes | labeling |
| Serial numbers | 2479873, 2479898, 2479944, 2479969 |
| Model numbers | 130-3253, 136-32-53 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.