Recall Z-2036-2017
Smith & Nephew, Inc. · initiated March 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Codes / lots: Lot 16DM15958
Reason for recall
This lot of left plates were laser etched and packaged as right plates.
FDA-determined cause: Mixed-up of materials/components
Action taken
Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.
Details
- Recall number
- Z-2036-2017
- Initiated
- March 22, 2017
- Posted by FDA
- April 14, 2017
- Terminated
- June 3, 2022
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 12 units
- Distribution
- Internationally to the country of : India
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN