Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devic

FDA device recall Z-0027-2016 · posted 2015-10-06 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FSM

Quantity affected

18 units

Distribution

Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.

Date initiated

2015-08-11

Date posted

2015-10-06

Date terminated

2016-03-15

Location

Warsaw, IN