Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Reported: February 13, 2013 Initiated: November 5, 2012 #Z-0787-2013
Product Description
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. 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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 26 Units
- Distribution
- Distributed in the states of TN, FL, VA, WA and NV.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.. Recalled by Exactech, Inc.. Units affected: 26 Units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2013. Severity: Moderate. Recall number: Z-0787-2013.
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