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U.S. Department of Health and Human Services

Class 2 Device Recall PERILOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE

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  Class 2 Device Recall PERILOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE see related information
Date Initiated by Firm July 20, 2010
Date Posted August 31, 2010
Recall Status1 Terminated 3 on November 17, 2011
Recall Number Z-2314-2010
Recall Event ID 56402
510(K)Number K033669  
Product Classification Plate, fixation, bone - Product Code HRS
Product PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttlingen, Germany. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation.
Code Information Lot number 08GM01779
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Dave Archer
901-399-5427
Manufacturer Reason
for Recall		 Inner packaging of sterile product was not sealed. Lack of sterility assurance.
FDA Determined
Cause 2		 Packaging
Action Smith & Nephew issued an "Urgent:: Medical Device Recall" letter dated July 20, 2010 to consignees (International distributors), identifying the issue and affected product. Consignees were requested to identify and quarantine affected stock, and cease distribution. Consignees were instructed to contact Smith and Nephew for a Return Authorization number. The Return Authorization number and an inventory of affected devices are to be recorded on the Verification Section of the notification letter and faxed to the firm. Affected stock is to be sent to Smith & Nephew. Consignees were requested to notify anyone to whom the product was distributed to also contact the firm for return of the product. Smith & Nephew can be contacted at 1-901-399-5441.
Quantity in Commerce 10 units
Distribution Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SMITH & NEPHEW, INC.
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