Skip to content
Recall Observatory FDA recall evidence

Device product

Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

Z-1235-2015

February 05, 2015

Class II

Product summary

Firm
Zipline Medical
Event
Event 70466
Status
Terminated
Classification
Class II
Quantity
3109 devices, total all model numbers
Official record key
device-enforcement:Z-1235-2015

Official wording

Reason: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Code information: Lot 1002750, Exp 2016-09

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Field note

Send feedback

We'll only use this to respond to your feedback.