Zimmer Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0646-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 9, 2015

Date Posted: January 20, 2016

Recall Number: Z-0646-2016

Event ID: 72938

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.

Status: Terminated

Product Quantity: 400

Code Information:

Item 00-2359-058-35, Lot 62918019 PERI LOCKING SCREW 3.5MM Item 00-2359-014-24, Lot 62896038 PERI LOCKING SCREW 2.4MM

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated