Mitek Screw and Washer Depth Gauge — Class II medical device recall Z-0208-2019
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2018-10-31, distributed nationwide. The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual l
| Recall number | Z-0208-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2018-08-30 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CN, DK, GB, IT, JO, JP, NL, PL, SE, SI, TR |
| Quantity | 401 |
| UPC / GTIN / UDI-DI | 10886705005390 |
| Lot numbers | 0005178, 0009101, 0009181, 0102157, 0103045, 0205355, 0207451, 0208597, 0301615, 0302184, 0303337, 0311333, 0311389, 0512552, 0605571, 0612501, 0707512, 0710501, 0801536, 0809117, 0905130, 0912100, 1000064514, 1000196842, 1000415749, 1000431580, 1000661713, 1001119996, 1002144, 1006113, 1008120, 1103103, 1103107, 1105132, 1112106, 1201104, 950229, 961232, 970198, 971229 and 6 more |
Product
Mitek Screw and Washer Depth Gauge, Product Code 219024
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0208-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.