Overview of recall records associated with Smith & Nephew, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 124.
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to…
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode…
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not…
The affected products were inadvertently packaged with an incorrect screw component.
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that…
The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that…
The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that…
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient…
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient…
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
This page summarizes recall records in which the official source identifies Smith & Nephew, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
