CLASS II Device recall · Reported 28 Jun 2017 · FDA Enforcement Report

DePuy Mitek Latarjet Experience-Combo Screw Driver Product recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek Latarjet Experience-Combo Screw Driver, distributed in 8 states. The recall was initiated on 12 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02

Quantity recalled173 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2615-2017
FDA event ID: 77252
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 12 May 2017
FDA classified: 20 Jun 2017
Reported: 28 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 May 2017	Recall initiated by company
20 Jun 2017	Classified by FDA	+39 days
28 Jun 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Colorado Georgia Massachusetts Michigan Ohio Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 77252

This product is part of a recall event; the main page for the event is DePuy Mitek Latarjet Experience Extraction Driver Product recalled.

Reported	Class	Recall	Company	Reason	Where
28 Jun 2017	CLASS II	DePuy Mitek Latarjet Experience Extraction Driver Product recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	8 states
28 Jun 2017	CLASS II	DePuy Mitek Latarjet Experience Coracoid Drill Product recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	8 states
28 Jun 2017	CLASS II	DePuy Mitek Latarjet Experience Top Hat Tap Product recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	8 states
28 Jun 2017	CLASS II	DePuy Mitek Latarjet Experience Coracoid Top Hat Drill Product recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	8 states

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All 51

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