Z-0027-2016Class II

Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable...

Name: Z-0027-2016 Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable...
Creator: Zimmer, Inc.
Published: 2015-08-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-08-11 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization... on 2015-08-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0027-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-11
Posted: 2015-10-06
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
Product: 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.
Product code: FSM Tray, Surgical, Instrument
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
Root cause tag: manufacturing process
FDA 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 in commerce: 18 units
Distribution: Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Product codes and lots: Item No. 00-4836-080-00; Lot 56555128

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0027-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-06

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)