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Recall Observatory FDA recall evidence

Device product

Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

Z-0813-2018

October 23, 2017

Class II

Product summary

Firm
Alto Development Corp
Event
Event 79274
Status
Terminated
Classification
Class II
Quantity
411,486 units
Official record key
device-enforcement:Z-0813-2018

Official wording

Reason: Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

Code information: 080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)

Distribution pattern: Worldwide Distribution - USA Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility