Recall Z-1523-2015 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Gmbh
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
| Date | Apr 27, 2015 (initiated Mar 18, 2015) |
| Status | Terminated |
| Reason | Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. 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 1-877-946-2761 between 8:00 am and 5:00pm EST. |
| Quantity | 30 units |
| Distribution | Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.