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U.S. Department of Health and Human Services

Class 2 Device Recall LATARJET EXPERIENCECombo Screw Driver

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  Class 2 Device Recall LATARJET EXPERIENCECombo Screw Driver see related information
Date Initiated by Firm May 12, 2017
Create Date June 20, 2017
Recall Status1 Terminated 3 on October 03, 2018
Recall Number Z-2615-2017
Recall Event ID 77252
510(K)Number K110763  K091694  K083096  
Product Classification Screw, fixation, bone - Product Code HWC
Product DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver
Product Code: 288211

Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Code Information GTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact SAME
508-880-8100
Manufacturer Reason
for Recall		 Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
FDA Determined
Cause 2		 Component design/selection
Action DePuy Mitek issued recall letter dated May 12, 2017 advising of the problem and requesting return of the product. A Response Form is to be completed and returned. Questions: contact your DePuy Synthes Mitek Sales Consultant or Carolyn Somerville, DePuy Mitek, Inc. (via telephone: 508.828.3647 Fax: 508.828.3762 or via email: DPYUS-MitekFieldActions@its.jnj.com).
Quantity in Commerce 173 units
Distribution US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
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 = HWC and Original Applicant = T.A.G. MEDICAL PRODUCTS
510(K)s with Product Code = HWC and Original Applicant = T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
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