Recall Z-2597-2010 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
| Date | Sep 28, 2010 (initiated Jul 1, 2010) |
| Status | Terminated |
| Reason | The affected instruments are discolored and/or have a sticky residue on the end. |
| Root cause | Packaging change control |
| Action | The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755. |
| Quantity | 50 |
| Distribution | US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.