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
This recall has been terminated (originally issued May 12, 2017).
- Recall Initiated
- May 12, 2017
- Terminated
- October 3, 2018
- Recall Number
- Z-2619-2017
- Quantity
- 115 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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
Distribution
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Lot / Code Info
GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04
Root Cause
Component design/selection
Action Taken
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).