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U.S. Department of Health and Human Services

Class 2 Device Recall PERILOC TARGETER

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  Class 2 Device Recall PERILOC TARGETER see related information
Date Initiated by Firm June 29, 2020
Create Date August 10, 2020
Recall Status1 Terminated 3 on February 18, 2022
Recall Number Z-2777-2020
Recall Event ID 85946
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.
Code Information Product Number: 71173400, Lot Number: 16GM20026
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		 The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
FDA Determined
Cause 2		 Process design
Action The firm sent a letter to customers dated 06/29/2020 and titled "Urgent Medical Device Recall Notice". The letter informs customers of a field action to voluntarily remove a single lot of PeriLoc Targeters due to a manufacturing error. Customers should inspect their inventory and locate any devices from the listed product and batch numbers enclosed with the Recall Notice, and quarantine them immediately. Sales reps or distributors, should notify customers of the field action and ensure that the required actions are complete. Customers should completed a form identifying if they have product to return or no product to return. Customers returning product should list batches and quantities that are being returned. Completed forms should be signed and send to FieldActions@smith-nephew.com. The firm's contact information: FieldActions@smith-nephew.com. T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)
Quantity in Commerce 3 units
Distribution U.S Nationwide including in the states of IN and TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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