DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk
DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source identifies this as an FDA Class II recall involving a medical device with a risk of intra-operative breakage, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 184 units of the LATARJET EXPERIENCE Coracoid Top Hat Drill (Product Code 288202). The recall is due to a potential defect in the Combo Screw Driver (Product Code 288211) tip, which has 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 foreign countries including Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the UK. Specific lot codes include 16C01, 16E03, 16R01, 17A01, and 17B01.
Healthcare providers should stop using the affected product and contact DePuy Mitek for instructions on return or replacement. This is an FDA Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 184
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 (5)
- GTN: 01)10886705026807 Lot codes: 16C01
- 16E03
- 16R01
- 17A01
- 17B01
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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