Food, drugs, devices › DePuy Mitek, Inc., a Johnson & Johnson Co.
Device recall: Mitek Screw and Washer Depth Gauge, Product Code 219024
DePuy Mitek, Inc., a Johnson & Johnson Co. (Raynham, MA) initiated this device recall on 30 Aug 2018; FDA lists 1 product record under event 81059, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 5 Jun 2020. Initiation: voluntary: firm initiated. DePuy Mitek, Inc., a Johnson & Johnson Co. has 16 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA.
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0208-2019 | Mitek Screw and Washer Depth Gauge, Product Code 219024 | 401 | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for DePuy Mitek, Inc., a Johnson & Johnson Co.
All 16 events for DePuy Mitek, Inc., a Johnson & Johnson Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.