| Class 2 Device Recall LATARJET EXPERIENCE Extraction Driver | |
Date Initiated by Firm | May 12, 2017 |
Create Date | June 20, 2017 |
Recall Status1 |
Terminated 3 on October 03, 2018 |
Recall Number | Z-2619-2017 |
Recall Event ID |
77252 |
510(K)Number | K083096 K091694 K110763 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | DePuy 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
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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 | 115 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HWC 510(K)s with Product Code = HWC
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