Recall Z-1024-2017 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
| Date | Dec 19, 2016 |
| Status | Terminated |
| Reason | Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL) LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimme |
| Quantity | 36 |
| Distribution | USA (nationwide) and Internationally to ARGENTINA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110555 | ARCOMXL ACTIVE ARTICULATION Biomet Manufacturing Corp, Mar 24, 2011 |