Agency classClass IIOur severity:Severe FDA (Devices)·Z-0111-2016·Announced 2015-10-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Instrument
Hazard: fracture
foreign-body-retention
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

Distributed in 40 states:

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · fracture