Specialist 2 Intramedullary — Class II medical device recall Z-0111-2016
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-10-14, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Ro
| Recall number | Z-0111-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-09-08 |
| Classified | 2015-10-07 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2018-07-03 |
| Distributed | AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, EG, FR, GB, GR, IL, IN, IT, KR, MX, NO, NZ, PA, PE, PL, RU, SG, SI, UY, VE, VN, ZA |
| Quantity | 7,488 |
| UPC / GTIN / UDI-DI | 10603295246893 |
| Lot numbers | C3JHF4, C3JHN4, C3JHS4, C4GA54, C4GBT4, C4GCC4, C52F14, C52F74, C52GL4, C52GV4, C67N14, C98BF4, D95AN4, DE1FA4, DE5P34, DE5RP4, DF4H44, DG9L64, DG9LK4, DJ5E34, DK3E34, DK3FE4, E2SD44, EB5FV4, EB5GH4, EC9JY4, EF4DJ4, EJ7A34, EJ7AP4, ES2G64, ES2HA4, ES2HY4, EX5L44, EX5MS4, FA4G94, FD8MP4, FH8JA4, FH8JX4, H0100, H0199 and 30 more |
| Model numbers | 96-6120 |
Product
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ 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 with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High Performance (HP) Primary Knee Instruments
Reason for recall
DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
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-0111-2016. 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.