Recall Z-2712-2011 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.
| Date | Jun 30, 2011 (initiated Apr 7, 2011) |
| Status | Terminated |
| Reason | When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the pr |
| Quantity | 469 units both products |
| Distribution | Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.