DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder inst

Is my product affected?

DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

• UPC 10886705026814

Check against the official notice below — it lists the full affected range.

What happened

DePuy Mitek, Inc., a Johnson & Johnson company, has recalled 153 units of the Combo Screw Driver (Product Code 288211) used with the DePuy Mitek LATARJET EXPERIENCE Top Hat Tap product. The screw driver tip has an increased potential to break during surgery when used at an angle off-axis to the screw. The affected units were distributed in the United States (Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio, and Washington) and internationally (Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the United Kingdom). The recalled lot codes are: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, and 17C03.

The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 153 units Lot/code info: GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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All FDA (Device enforcement) recalls