DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk
DePuy Mitek is recalling LATARJET Coracoid Drills because the Combo Screw Driver tip may break during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical instrument that could break during a procedure, posing a significant risk of injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 184 units of the LATARJET EXPERIENCE Coracoid Drill (Product Code 288201). 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 products were 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, the Netherlands, Poland, and the UK. The specific lot codes involved are 16C01, 16E01, 16E02, 16E03, and 17B01.
Healthcare providers should stop using the affected Combo Screw Driver tips and contact DePuy Mitek for instructions on return or replacement. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 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)10886705026791 Lot Codes: 16C01
- 16E01
- 16E02
- 16E03
- 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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