Z-0208-2019Class II

Mitek Screw and Washer Depth Gauge, Product Code 219024

Name: Z-0208-2019 Mitek Screw and Washer Depth Gauge, Product Code 219024
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2018-08-30
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2018-08-30 / Terminated / root cause: design

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Mitek Screw and Washer Depth Gauge, Product Code 219024 on 2018-08-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0208-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-10-23
Terminated: 2020-06-05
Recalling firm: DePuy Mitek, Inc.
Product: Mitek Screw and Washer Depth Gauge, Product Code 219024
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 401
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0208-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)