DePuy Mitek, Inc., a Johnson & Johnson Co.: 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

Agency Publication Date: June 20, 2017

Affected Products

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

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

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Product: DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

GTN: 01)10886705026791 Lot Codes: 16C01, 16E01, 16E02, 16E03, 17B01

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Product: DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

GTN: 01)10886705026807 Lot codes: 16C01, 16E03, 16R01, 17A01, 17B01

Lot Numbers:

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Product: 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

GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03

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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

GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77252

Status: Resolved

Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufactured In: United States

Units Affected: 5 products (173 units; 184 units; 184 units; 153 units; 115 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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

Lot Numbers:

codes

GTN: 01)10886705026791 Lot Codes: 16C01, 16E01, 16E02, 16E03, 17B01

Lot Numbers:

Codes

GTN: 01)10886705026807 Lot codes: 16C01, 16E03, 16R01, 17A01, 17B01

Lot Numbers:

codes

GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03

Lot Numbers:

codes

GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04

Lot Numbers:

codes