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Recall Observatory FDA recall evidence

Device product

1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402

Z-1335-2020

August 28, 2019

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 84772
Status
Terminated
Classification
Class II
Quantity
660 units
Official record key
device-enforcement:Z-1335-2020

Official wording

Reason: The product do not meet certain internal testing specifications.

Code information: GTIN: 10705031236059 Lot Numbers: PAH073, PAH054 Expiration Date: 12/31/2020

Distribution pattern: International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product do not meet certain internal testing specifications.