Overview of recall records associated with Smith & Nephew, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 124.
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Multiple or incorrect expiration dates were provided on the affected designation labels.
The products were improperly heat treated.
The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
A manufacturing error resulted in out of specification R3 Acetabular Shells
A manufacturing error resulted in out of specification R3 Acetabular Shells
A manufacturing error resulted in out of specification R3 Acetabular Shells
A manufacturing error resulted in out of specification R3 Acetabular Shells
A manufacturing error resulted in out of specification R3 Acetabular Shells
A manufacturing error resulted in out of specification R3 Acetabular Shells
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create…
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create…
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
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.
