Recall Z-0777-04 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Biomet, Inc.
Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
| Date | Jul 20, 2004 (initiated Feb 23, 2004) |
| Status | Terminated |
| Reason | The locking ring was not included and the shoulder implanted without the locking ring. |
| Root cause | Other |
| Action | The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians. |
| Quantity | 7 |
| Distribution | California, Florida, Washington, Germany and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002998 | BIOMET BI-POLAR SHOULDER SYSTEM Biomet, Inc., Oct 6, 2000 |