Recall Z-0027-2016 ยท FSM Tray, Surgical, Instrument
Zimmer, Inc.
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
| Date | Oct 6, 2015 (initiated Aug 11, 2015) |
| Status | Terminated |
| Reason | It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat |
| Root cause | Process control |
| Action | On 8/11/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. 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. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 a.m. and 5:00 p.m. EST. |
| Quantity | 18 units |
| Distribution | Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.