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U.S. Department of Health and Human Services

Class 2 Device Recall LATARJET EXPERIENCE Extraction Driver

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 Class 2 Device Recall LATARJET EXPERIENCE Extraction Driversee related information
Date Initiated by FirmMay 12, 2017
Create DateJune 20, 2017
Recall Status1 Terminated 3 on October 03, 2018
Recall NumberZ-2619-2017
Recall Event ID 77252
510(K)NumberK083096 K091694 K110763 
Product Classification Screw, fixation, bone - Product Code HWC
ProductDePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 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)10886705026944 Lot codes:  16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04  
Recalling Firm/
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information ContactSAME
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
ActionDePuy 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 Commerce115 units
DistributionUS: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
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 = HWC
510(K)s with Product Code = HWC
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