DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2018 - (Recall #: Z-0208-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Mitek Screw and Washer Depth Gauge, Product Code 219024

Product Classification:

Class II

Date Initiated: August 30, 2018

Date Posted: October 31, 2018

Recall Number: Z-0208-2019

Event ID: 81059

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.

Status: Terminated

Product Quantity: 401

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated