System 6 Aseptic Housing — Class II medical device recall Z-1066-2015
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-02-18, distributed nationwide. Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing withou
| Recall number | Z-1066-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-01-07 |
| Classified | 2015-02-09 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2016-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, CO, FR, HK, IN, KR, NL, PL, ZA |
| Quantity | 399 |
| Lot numbers | 13205, 13209, 13210, 13212 |
| Model numbers | 13205, 13209, 13210, 13212, 6126-120-000 |
Product
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
Reason for recall
Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.
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-1066-2015. 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.