Z-2618-2017 Class II Terminated
FDA device recall Z-2618-2017 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on May 12, 2017 and is designated Class II. 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 The recall status is terminated (terminated Oct 3, 2018). Affected quantity: 153 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 28, 2017
- Initiation Date
- May 12, 2017
- Termination Date
- Oct 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 units
Product description
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 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
Distribution pattern
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Code information
GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2618-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026