Recall Z-0169-2010 ยท LXH Orthopedic Manual Surgical Instrument
Biomet Microfixation, Inc.
Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1, BIOMET MICROFIXATION, INC., 150 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA Instrument used to pull up
| Date | Nov 10, 2009 (initiated Feb 19, 2009) |
| Status | Terminated |
| Reason | Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet plans to send letters to customers on February 19, 2009. Customers are told to discontinue use of the item and return it to Biomet Microfixation. The firm plans to follow up with an e-mail to their customers. Questions pertaining to this issue, should be directed to Christy Cain at 1.800.874.7711 or 904.741.4400. |
| Quantity | 22 |
| Distribution | AZ, CA, GA, IL, IN, NM, NY, TX, VA, Puerto Rico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.