Z-1114-2017 Class II Terminated
FDA device recall Z-1114-2017 was initiated by Zimmer Biomet, Inc. on Dec 16, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2017
- Initiation Date
- Dec 16, 2016
- Termination Date
- Jul 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
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.
Distribution Pattern
WI NJ CA MD WA LA MA TX
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1114-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026