Recall archive
55 recalls · page 3 of 3
Reported Mar 27, 2013
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2013
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage…
High riskUsing this product could cause serious injury, illness or death — stop using it now.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Screw due to an incorrect description on the label.…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2012
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted…
FDA (openFDA device enforcement)
Reported Aug 22, 2012
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details · Reason for recall — In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to…
FDA (openFDA device enforcement)
Reported Jul 11, 2012
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product details · Reason for recall — DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished…
18 more products in this recall
FDA (openFDA device enforcement)
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