Recall Z-0198-2010 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks.
| Date | Nov 13, 2009 (initiated Aug 3, 2009) |
| Status | Terminated |
| Reason | Manufacturing material may be present on the surface of the implant. |
| Root cause | Manufacturing material removal |
| Action | 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 Certificat |
| Quantity | 104 |
| Distribution | Worldwide Distribution -- USA, Brazil, Canada, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953337 | BETA HIP PROSTHESIS Zimmer, Inc., Jan 22, 1996 |