Recall Z-1696-2015 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
| Date | May 29, 2015 (initiated Apr 30, 2015) |
| Status | Terminated |
| Reason | Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response. |
| Root cause | Process control |
| Action | On 4/30/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications dated April 30, 2015 were sent to the affected distributors, hospital Risk Managers, and surgeons via courier; all distributors were also notified via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. |
| Quantity | 1,689 |
| Distribution | Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.