RecallRadar

FDA Device recall Z-1066-2015

System 6 Aseptic Housing

On 2015-02-18 the FDA classified a Class II recall of System 6 Aseptic Housing by Stryker Instruments Div, citing 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 produ….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1066-2015
ClassificationClass II
Statusterminated
Initiated2015-01-07
Published2015-02-18
Last updated2026-09-13 11:53 UTC
CompanyStryker Instruments Div
DistributionUS

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

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.

Identifiers

code_infoPart No. 6126-120-000, Lots 13205, 13209, 13210, 13212

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.