Z-0646-2016Class II

Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking...

Name: Z-0646-2016 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking...
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 Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length... on 2015-12-09. FDA classified it as Class II and gives the reason as "Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while...". 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-0646-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Posted: 2016-01-13
Terminated: 2016-11-08
Recalling firm: Zimmer GmbH
Product: Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.
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. If after reviewing this notification you 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: 400
Distribution: Worldwide Distribution-US including the states of CA, NY, PA, AL, FL, GA, ID, WI, MO, SC, NC, and ME, and the countries of Brazil, Dominican Republic, Taiwan, China, Uruguay, Australia, Japan, Malaysia, India, Belgium, France, Italy, Netherlands, Poland, United Arab Emirates, and Canada.
Product codes and lots: Item 00-2359-058-35, Lot 62918019 PERI LOCKING SCREW 3.5MM Item 00-2359-014-24, Lot 62896038 PERI LOCKING SCREW 2.4MM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0646-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0646-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 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)