Z-0971-2013 Class II Terminated
FDA device recall Z-0971-2013 was initiated by DePuy Orthopaedics, Inc. on Feb 5, 2013 and is designated Class II. Reason for recall: Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. The recall status is terminated (terminated Jan 6, 2014). Affected quantity: 4000; 2600 in USA.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2013
- Initiation Date
- Feb 5, 2013
- Termination Date
- Jan 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4000; 2600 in USA
Product Description
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.
Reason for Recall
Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
Distribution Pattern
Worldwide Distribution - USA Nationwide.
Code Information
Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54 C4GCC4 C4GBT4 C52F74 H1108 C52GV4 H1208 C52GL4 C67N14 C98CS4 H0109 C98BF4 DE5P34 H0309 DE5RP4 DF4H44 DG9LK4 H0409 DG9L64 DJ5E34 DK3E34 H0509 DK3FE4 EB5FV4 H0210 D95AN4 EB5GH4 H0310 EC9JY4 EF4DJ4 EJ7AP4 H0410 ES2G64 H0510 EJ7A34 ES2HA4 H0610 ES2HY4 H0710 EX5L44 EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4 FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0971-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026