Recall Z-0517-2009 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
| Date | Jan 7, 2009 (initiated Jul 18, 2008) |
| Status | Terminated |
| Reason | The set screw may not fully seat, which will prevent the handle from mating to the instrument during use. |
| Root cause | Process control |
| Action | Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be direct |
| Quantity | 41 of all products. |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.