DePuy Mitek LATARJET Extraction Driver Recalled for Breakage Risk
DePuy Mitek is recalling 115 units of the LATARJET EXPERIENCE Extraction Driver because the tip may break during surgery when used at an angle.
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 115 units of the LATARJET EXPERIENCE Extraction Driver (Product Code 288216). The recall is due to the Combo Screw Driver (Product Code 288211) tip having an increased potential to break intra-operatively when being 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. Specific lot codes include 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, and 17B04.
Healthcare providers should stop using the affected devices and contact DePuy Mitek for instructions on returning or replacing the product.
The recalled product
- Product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 115
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 (7)
- GTN: 01)10886705026944 Lot codes: 16D01
- 16D02
- 16E02
- 16J01
- 17B02
- 17B03
- 17B04
Distribution
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.
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