Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2546-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM

Product Classification:

Class II

Date Initiated: July 22, 2014

Date Posted: September 3, 2014

Recall Number: Z-2546-2014

Event ID: 68818

Reason for Recall:

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Status: Terminated

Product Quantity: 972,125 units

Code Information:

Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated