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
FDA Recall Z-2036-2017 · Posted 2017-04-14
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2017-03-22
Date Terminated2022-06-03
Product Quantity12 units
Reason for Recall
This lot of left plates were laser etched and packaged as right plates.
Firm Action
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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Internationally to the country of : India
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.