Reported Mar 7, 2018 · Terminated

Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts…

Alto Development Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alto Development Corp · 5206 Asbury Rd · Wall Township, NJ · 07727-3609

Is this the product you have?

  • 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.
Lot codes and dates
    • 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)
Amount recalled
411,486 units

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 30, 2019 · Data as of Sep 19, 4:47 PM UTC

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