Recall Z-1122-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
| Date | Feb 17, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. |
| Root cause | Packaging process control |
| Action | Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM. |
| Quantity | 17 |
| Distribution | Distributed in the states of VA and TX and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030055 | MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS Biomet, Inc., Aug 11, 2003 |