Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1114-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Product Classification:

Class II

Date Initiated: December 16, 2016

Date Posted: February 8, 2017

Recall Number: Z-1114-2017

Event ID: 76082

Reason for Recall:

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

Status: Terminated

Product Quantity: 16

Code Information:

Part # Lot # UDI CP113462 646200 (01) 0 0880304 51008 1 (17) 250928 (10) 646200 CP113462 690040 (01) 0 0880304 51008 1 (17) 260714 (10) 690040 CP113462 003620 (01) 0 0880304 51008 1 (17) 260324 (10) 003620 CP113462 498380 (01) 0 0880304 51008 1 (17) 250929 (10) 498380 CP113462 690050 (01) 0 0880304 51008 1 (17) 260622 (10) 690050 CP113462 539760 (01) 0 0880304 51008 1 (17) 251007 (10) 539760 CP113462 409190 (01) 0 0880304 51008 1 (17) 260417 (10) 409190 CP113462 799300 (01) 0 0880304 51008 1 (17) 260802 (10) 799300 CP113462 460990 (01) 0 0880304 51008 1 (17) 260416 (10) 460990

Distribution Pattern:

WI NJ CA MD WA LA MA TX

Voluntary or Mandated:

Voluntary: Firm initiated