Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PERILOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATEsee related information
Date Initiated by FirmJuly 20, 2010
Date PostedAugust 31, 2010
Recall Status1 Terminated 3 on November 17, 2011
Recall NumberZ-2314-2010
Recall Event ID 56402
510(K)NumberK033669 
Product Classification Plate, fixation, bone - Product Code HRS
ProductPERI-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 ContactDave 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
ActionSmith & 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 Commerce10 units
DistributionWorldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HRS
-
-