Recall Z-0208-2019— 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 2018-08-30, terminated 2020-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Mitek Screw and Washer Depth Gauge, Product Code 219024. Reason: The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole..
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-30
- Terminated
- 2020-06-05
- Firm location
- Raynham, MA, United States
Product description
Mitek Screw and Washer Depth Gauge, Product Code 219024
Reason for recall
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
Data sourced from openFDA. This site is unofficial and independent of the FDA.