Recall Z-0990-2009 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
| Date | Feb 27, 2009 (initiated Dec 19, 2008) |
| Status | Terminated |
| Reason | The c-clip located near the connection end may fracture or fall off during use in surgical procedures. |
| Root cause | Labeling design |
| Action | U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer |
| Quantity | 1,461 of both products. |
| Distribution | Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.