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U.S. Department of Health and Human Services

Class 2 Device Recall 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12MM

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  Class 2 Device Recall 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12MM see related information
Date Initiated by Firm October 06, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on July 15, 2016
Recall Number Z-0167-2016
Recall Event ID 72345
510(K)Number K063049  
Product Classification Plate, fixation, bone - Product Code HRS
Product 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Code Information Part Number 202.212 Lot Number 3420620 
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
610-719-6500
Manufacturer Reason
for Recall
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
FDA Determined
Cause 2
Packaging
Action Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to: Credit/Returns, Synthes. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 1-866-792-5446 or Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. For further questions please call 610-719-6500.
Quantity in Commerce 98
Distribution US Distribution to the state of : 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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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