Recall Z-0181-2009 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
| Date | Oct 24, 2008 (initiated Jul 28, 2008) |
| Status | Terminated |
| Reason | The pin and clip may fracture during use. |
| Root cause | Device Design |
| Action | Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance. |
| Quantity | 85 |
| Distribution | Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.