Smith & Nephew, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1028-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Product Classification:

Class II

Date Initiated: February 19, 2019

Date Posted: March 27, 2019

Recall Number: Z-1028-2019

Event ID: 82193

Reason for Recall:

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"

Status: Terminated

Product Quantity: 58 units

Code Information:

Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027

Distribution Pattern:

US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

Voluntary or Mandated:

Voluntary: Firm initiated