Z-0027-2016 Class II Terminated
FDA device recall Z-0027-2016 was initiated by Zimmer, Inc. on Aug 11, 2015 and is designated Class II. 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… The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2015
- Initiation Date
- Aug 11, 2015
- Termination Date
- Mar 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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
Distribution Pattern
Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Code Information
Item No. 00-4836-080-00; Lot 56555128
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0027-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026