smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
This recall has been terminated (originally issued February 19, 2019).
- Company
- Smith & Nephew Inc
- Recall Initiated
- February 19, 2019
- Terminated
- May 21, 2021
- Recall Number
- Z-1028-2019
- Quantity
- 58 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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
US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
Lot / Code Info
Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027
Root Cause
Packaging process control
Action Taken
The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out.