Recall Z-2619-2017 ยท HWC Screw, Fixation, Bone
DePuy Mitek, Inc., a Johnson & Johnson Co.
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
| Date | May 12, 2017 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 115 units |
| Distribution | US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK |
| FDA record | Open on fda.gov |