Specialist 2 IM Rod — Class II medical device recall Z-0971-2013
Terminated recall by DePuy Orthopaedics, Inc., reported 2013-03-27, distributed nationwide. Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been upd
| Recall number | Z-0971-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-02-05 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-01-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,000 |
| Reason classes | device malfunction |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0971-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.