Mitek Screw and Washer Depth Gauge, Product Code 219024
This recall has been terminated (originally issued August 30, 2018).
- Recall Initiated
- August 30, 2018
- Terminated
- June 5, 2020
- Recall Number
- Z-0208-2019
- Quantity
- 401
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.
Lot / Code Info
UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 950229 0205355 961232 0207451 970198 0208597 971229 0301615 980585 0302184 9809121 0303337 990765 0311333 C000007655 0311389 C000012527 0512552 C000020182 0605571 1000196842 0612501 1000415749 0707512 1000431580 0710501 1000661713 0801536 1001119996 0809117 1002144 0905130 1006113 0912100 1008120 1000064514 1103103
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Recall Notification letters were sent to customers on 8/30/18. Updated Urgent Medical Device Recall notification letters were sent to customers on 9/18/18