DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints
DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device that fractured and left a portion inside patients, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120). The recall is due to complaints that the rod fractured during use, leaving a portion of the rod in patients.
The affected instrument is used in primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device and distal femoral cutting block, as well as with the IM tibial resection. The product was distributed worldwide, including in the United States and numerous international markets.
Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the recall and potential replacement or repair of the affected instruments.
The recalled product
- 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
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 7,488
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CATALOG NO. : 96-6120
- GTIN NO.: 10603295246893
- Lots: Manufactured with 455 Stainless Steel
- Labeled Lot #s-C98CS4
- DE5P34
- DE5RP4
- D95AN4
- EB5FV4
- FA4G94
- DE1FA4
- DF4H44
- DG9LK4
- EB5GH4
- EC9JY4
- EF4DJ4
- FD8MP4
- FH8JA4
- DG9L64
- DJ5E34
- DK3E34
Distribution
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