Recall Z-0097-2021 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLo
| Date | Oct 9, 2020 (initiated Sep 3, 2020) |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. |
| Root cause | Process control |
| Action | All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the r |
| Quantity | 48 devices |
| Distribution | Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT Biomet, Inc., Sep 29, 2005 |