Recall Z-0925-2013 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
| Date | Mar 8, 2013 (initiated Feb 5, 2013) |
| Status | Terminated |
| Reason | The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes. |
| Root cause | Process control |
| Action | BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676. |
| Quantity | 58 |
| Distribution | Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.