Recall Z-2543-2014 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
| Date | Aug 22, 2014 (initiated Jul 30, 2014) |
| Status | Terminated |
| Reason | Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction letter dated, July 31, 2014, was issued to consignees. The letter identified the affected product, the problem, the risks, and responsibilities. Risk managers and surgeons are to review the notification and the updated surgical technique provided in Attachment 1; as well as, ensure that all affected personnel are aware of the contents. Questions or concerns should be directed to Zimmer customer call center at 1-877-946-2761. |
| Quantity | 2,248 units |
| Distribution | Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.