DePuy Mitek LATARJET Combo Screw Driver Recalled for Breakage Risk
DePuy Mitek is recalling 173 LATARJET Combo Screw Drivers 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 poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 173 units of the LATARJET EXPERIENCE-Combo Screw Driver (Product Code 288211). The product is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft.
The recall was initiated because the screw driver tip has an increased potential to break intra-operatively when being used at an angle off-axis to the screw. The affected units are 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.
Healthcare providers should stop using the affected devices and contact DePuy Mitek for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 173
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 (6)
- GTN: 01)10886705026890 Lot codes: 16D02
- 16E01
- 16J01
- 17A01
- 17B01
- 17B02
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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