Recall Z-0701-2008 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.
| Date | Feb 5, 2008 (initiated Oct 18, 2007) |
| Status | Terminated |
| Reason | The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component. |
| Root cause | Process control |
| Action | Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations. |
| Quantity | 141 total for all recalls Z-0700-0705-2008 |
| Distribution | Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.