The Recall Desk
HighFDA (Devices)·Z-2618-2017·Announced 2017-06-28

DePuy Mitek Top Hat Tap Screw Driver Tip Recall

DePuy Mitek is recalling 153 units of the LATARJET EXPERIENCE Top Hat Tap because the Combo Screw Driver tip may break during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of intra-operative breakage, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 153 units of the LATARJET EXPERIENCE Top Hat Tap (Product Code 288203). The recall is due to the Combo Screw Driver (Product Code 288211) tip having an increased potential to break intra-operatively when used at an angle off-axis to the screw.

The affected product is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft. The recall covers units distributed in the United States (AZ, CA, CO, GA, MA, MI, OH, WA) and in foreign countries including Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the UK. Affected lot codes include 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, and 17C03.

Healthcare providers should stop using the affected Combo Screw Driver tip and contact DePuy Mitek for further instructions regarding the recall.

The recalled product

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
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 5 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · DePuy Mitek, Inc., a Johnson & Johnson Co.

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