Z-1028-2019 Class II Terminated
FDA device recall Z-1028-2019 was initiated by Smith & Nephew, Inc. on February 19, 2019 and is designated Class II. 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" The recall status is terminated (terminated May 21, 2021). Affected quantity: 58 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- February 19, 2019
- Termination Date
- May 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 units
Product Description
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
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"
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
Code Information
Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027