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Recall Observatory FDA recall evidence

Device 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

Z-2615-2017

May 12, 2017

Class II

Product summary

Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Event
Event 77252
Status
Terminated
Classification
Class II
Quantity
173 units
Official record key
device-enforcement:Z-2615-2017

Official wording

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

Code information: GTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02

Distribution pattern: US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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