Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
- Company
- Smith & Nephew Inc
- Recall Initiated
- October 25, 2021
- Recall Number
- Z-0265-2022
- Quantity
- 224 units
- Firm Location
- Memphis, TN
Reason for Recall
The labels on the packages of screws were switched.
Distribution
Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Lot / Code Info
REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.
Root Cause
Error in labeling
Action Taken
The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.