Z-0654-2016Class II

Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer...

Name: Z-0654-2016 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer...
Creator: Zimmer Biomet, Inc.
Published: 2015-12-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-12-09 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual... on 2015-12-09. FDA classified it as Class II and gives the reason as "The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0654-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Posted: 2016-01-14
Terminated: 2016-11-08
Recalling firm: Zimmer GmbH
Product: Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 12/9/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital risk managers 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. Specifically, customers were asked to review the notification and ensure all affected personnel are aware of the information; assist the Zimmer Biomet sales representative with the quarantine and removal of any of the identified affected product; and complete and return the Certificate of Acknowledgement form. If after reviewing this notification customers have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.
Quantity in commerce: 52
Distribution: Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
Product codes and lots: Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0654-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14

Product code HRS

K060710Class IIUniversal Locking System, 3.5Mm Plates and Screws-4936 Plates,4835 ScrewsZimmer, Inc. / cleared 2006-04-26

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)