FDA Device recall Z-0208-2019
Mitek Screw and Washer Depth Gauge, Product Code 219024
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Mitek Screw and Washer Depth Gauge, Product Code 219024 by Depuy Mitek A Johnson And Johnson, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0208-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-30 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | US |
Product
Mitek Screw and Washer Depth Gauge, Product Code 219024
Reason
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.
Identifiers
| code_info | UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 9502…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2019%22
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