Medical Device Recall: Z-0027-2016

FDA Recalls dataset · Firm: Zimmer, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2015-08-11 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-2016.

Recall Res Number
Z-0027-2016
Recalling Firm / Manufacturer
Zimmer, Inc.
FEI Number
1000220733
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2015-08-11
Date Posted
2015-10-06
Date Terminated
2016-03-15
Product Code
FSM
Event Number
72121
Product Quantity
18 units
Product Description 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.
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 Details 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.
Distribution Pattern Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Code Information / Serial Numbers Item No. 00-4836-080-00; Lot 56555128

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.