Z-0788-2013 Class II Terminated
FDA device recall Z-0788-2013 was initiated by Exactech, Inc. on Nov 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated Dec 24, 2013). Affected quantity: 26 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 13, 2013
- Initiation Date
- Nov 5, 2012
- Termination Date
- Dec 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 Units
Product Description
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.
Distribution Pattern
Distributed in the states of TN, FL, VA, WA and NV.
Code Information
Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0788-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026