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DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill recallZ-2617-2017 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated May 12, 2017

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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-2617-2017
Status
Terminated
Initiated by the company
May 12, 2017
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
184 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 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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 77252).

Sources and updates

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