Bacterin Elutia — Class II medical device recall Z-0936-2013
Terminated recall by Bacterin International, Inc., reported 2013-03-20, distributed nationwide. A portion of a silicone wound drain was found to be cracked.
| Recall number | Z-0936-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bacterin International, Inc., Belgrade, MT, United States |
| Recall initiated | 2013-01-28 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-07-08 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Model numbers | 7118 |
Product
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
Reason for recall
A portion of a silicone wound drain was found to be cracked.
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-0936-2013. 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.