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All Recalls

Every Depuy Orthopaedics, Inc. Recall

Sorted by most recent. Click any recall for full details.

105 recalls
High RiskFDA
Depuy Orthopaedics, Inc.
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replaceme...
Surgical Devices·3,861 affected·Nov 10, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with ...
Surgical Devices·7,944 affected·Nov 10, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i...
Medical Devices·19 affected·Nov 7, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Medical Devices·3,082 affected·Oct 15, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the sur...
Medical Devices·875 affected·Sep 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to...
Surgical Devices·65 affected·Aug 27, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgica...
Surgical Devices·10,467 affected·Jun 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf...
Surgical Devices·814 affected·Jun 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product U...
Medical Devices·21,675 affected·Mar 28, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged...
Medical Devices·137 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hing...
Medical Devices·128 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged...
Medical Devices·134 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinge...
Medical Devices·129 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hing...
Medical Devices·130 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patien...
Medical Devices·2 affected·Dec 9, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxima...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxim...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal...
Medical Devices·29,235 affected·Nov 18, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Medical Devices·58 affected·Jul 11, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma...
Surgical Devices·4,000 affected·Feb 5, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET pe...
Medical Implants·118 affected·Nov 28, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into...
Medical Devices·12 affected·Aug 22, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to ...
Medical Implants·20 affected·Jul 24, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems we...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Ty...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyv...
Medical Devices·431 affected·May 16, 2012