Recall Z-2619-2017— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2017-05-12, terminated 2018-10-03. It names 3 FDA 510(k) clearances: K110763, K091694, K083096. 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. Reason: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-12
- Terminated
- 2018-10-03
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K110763 — LATARJET CORTICAL SCREW SET
- K091694 — MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
- K083096 — LATARJET CORTICAL SCREW SET
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
Data sourced from openFDA. This site is unofficial and independent of the FDA.