Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle — Class II medical device recall Z-1940-2012
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2012-07-11, distributed nationwide. Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage wi
| Recall number | Z-1940-2012 |
|---|---|
| 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 | 2012-05-04 |
| Classified | 2012-07-03 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2016-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, CA, CH, CN, CZ, DE, ES, FR, GB, GR, HR, HU, IT, LB, NL, NZ, PL, SG, TR, ZA |
| Quantity | 6,979 units |
| Reason classes | device malfunction |
Product
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Reason for recall
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
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-1940-2012. 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.