Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1066-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-01-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1066-2015
Date of alert
2015-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Instruments Div. of Stryker Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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