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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77252

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 12, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Mitek, Inc., a Johnson & Johnson Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

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
Recall number
Z-2615-2017
Initiated
May 12, 2017
Classification
Class II
Status
Terminated
Quantity
173 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

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

device · product 2 of 5

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

Z-2616-2017
Recall number
Z-2616-2017
Initiated
May 12, 2017
Classification
Class II
Status
Terminated
Quantity
184 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 3 of 5

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

Z-2617-2017
Recall number
Z-2617-2017
Initiated
May 12, 2017
Classification
Class II
Status
Terminated
Quantity
184 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 4 of 5

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

Z-2618-2017
Recall number
Z-2618-2017
Initiated
May 12, 2017
Classification
Class II
Status
Terminated
Quantity
153 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 5 of 5

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

Z-2619-2017
Recall number
Z-2619-2017
Initiated
May 12, 2017
Classification
Class II
Status
Terminated
Quantity
115 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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