Z-2041-2013 Class II Terminated
FDA device recall Z-2041-2013 was initiated by Zimmer, Inc. on Jun 7, 2013 and is designated Class II. Reason for recall: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface… The recall status is terminated (terminated Dec 15, 2014). Affected quantity: 192,355 all devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2013
- Initiation Date
- Jun 7, 2013
- Termination Date
- Dec 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192,355 all devices
Product Description
00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Reason for Recall
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Japan.
Code Information
all codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2041-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026