Mitek Screw and Washer Depth Gauge, Product Code 219024 recallZ-0208-2019 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Aug 30, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0208-2019
- Status
- Terminated
- Initiated by the company
- Aug 30, 2018
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 401
- Product code
- LXH
- 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.
Product description
Mitek Screw and Washer Depth Gauge, Product Code 219024
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 219024Depuy Mitek, LLC · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page