Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018
FDA device recall Z-0198-2010 · posted 2009-11-13 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Manufacturing material may be present on the surface of the implant.
- Action taken
- An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A "Dear Surgeon" letter will be issued to any hospitals where the devices have been implanted.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 104
- Distribution
- Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.
- Date initiated
- 2009-08-03
- Date posted
- 2009-11-13
- Date terminated
- 2009-12-15
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BETA HIP PROSTHESIS (K953337) | Zimmer, Inc. | 1996-01-22 |