VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTU
FDA device recall Z-2290-2010 · posted 2010-08-26 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect.
- Action taken
- The firm, Zimmer, Inc., sent an "URGENT: DEVICE REMOVAL" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots. For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 103
- Distribution
- Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
- Date initiated
- 2010-07-05
- Date posted
- 2010-08-26
- Date terminated
- 2011-01-12
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BETA HIP PROSTHESIS (K953337) | Zimmer, Inc. | 1996-01-22 |