DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver recallZ-2615-2017 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated May 12, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Component design/selection
What the company is doing
DePuy Mitek issued recall letter dated May 12, 2017 advising of the problem and requesting return of the product. A Response Form is to be completed and returned. Questions: contact your DePuy Synthes Mitek Sales Consultant or Carolyn Somerville, DePuy Mitek, Inc. (via telephone: 508.828.3647 Fax: 508.828.3762 or via email: [email protected]).
Recall details
- Recall number
- Z-2615-2017
- Status
- Terminated
- Initiated by the company
- May 12, 2017
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 173 units
- Product code
- HWC
- FDA submissions
- K083096, K091694, K110763
- Distribution
- US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Product description
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
Code information (models, lots, serial numbers)
GTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 288211Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall17 reports
Other devices under the same FDA submission
6 devices cleared under K083096, K091694, K110763 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BRISTOW LATARJET 285112Depuy Mitek, LLC · Screw, fixation, bone2 reports
- BRISTOW LATARJET 285122Depuy Mitek, LLC · Screw, fixation, bone2 reports
- BRISTOW LATARJET 285126Depuy Mitek, LLC · Screw, fixation, bone2 reports
- BRISTOW LATARJET 285111Depuy Mitek, LLC · Screw, fixation, bone1 report
- BRISTOW LATARJET 285121Depuy Mitek, LLC · Screw, fixation, bone1 report
- BRISTOW LATARJET 285142Depuy Mitek, LLC · Screw, fixation, bone1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 77252).
- Z-2616-2017 · TerminatedDePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting…
- Z-2617-2017 · TerminatedDePuy 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 su…
- Z-2618-2017 · TerminatedDePuy 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 t…
- Z-2619-2017 · TerminatedDePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by suppor…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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