Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Mitek Screw and Washer Depth Gauge, Product Code 219024

FDA Recall Z-0208-2019 · Posted None

Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-08-30
Date Terminated2020-06-05
Product Quantity401

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.

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

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑