Mitek Screw and Washer Depth Gauge, Product Code 219024
Check against the official notice below — it lists the full affected range.
DePuy Mitek, Inc., a Johnson & Johnson Company, has recalled the Mitek Screw and Washer Depth Gauge (Product Code 219024) due to a design offset that causes the device to provide inaccurate measurements. Specifically, the gauge reads approximately 3.2mm shorter than the actual length of the bone hole. A total of 401 units were affected across the United States in 32 states and internationally in 14 countries, including Australia, Canada, Japan, and the United Kingdom.
The recalled devices are identified by UDI 10886705005390 and include 44 specific lot numbers manufactured between 1995 and 2013. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 401 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.