Miltex Premium Grade Self-Lock Chisel Blade Handle — Class II medical device recall Z-1841-2016
Terminated recall by Integra York PA, Inc, reported 2016-06-08, distributed nationwide. One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the
| Recall number | Z-1841-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra York PA, Inc, York, PA, United States |
| Recall initiated | 2016-03-11 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, MX |
| Quantity | 678 chisel |
| Lot numbers | 97327 |
| Model numbers | 4-405 |
Product
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Reason for recall
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
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-1841-2016. 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.