Z-0813-2018Class II

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

Name: Z-0813-2018 Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create...
Creator: Alto Development Corp
Published: 2017-10-23
License: https://open.fda.gov/license/

Alto Development Corp / initiated 2017-10-23 / Terminated / root cause: packaging

FDA source

Alto Development Corp began a recall of 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... on 2017-10-23. FDA classified it as Class II and gives the reason as "Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0813-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2018-03-01
Terminated: 2019-04-30
Recalling firm: Alto Development Corp
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.
Product code: LRY Punch, Surgical
Reason for recall: Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: A&E Medical sent an Recall Notice Action Required letter dated October 20, 2017. Surgical Punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in a loss of sterility. Recent testing identified certain shipping configurations which may cause damage to the sterile barrier pouch if the Surgical Punches experience excessive movement from multiple drops during transport A&E is recalling all product currently on the market. Customer and Distributor Letters were sent with Acknowledgement Form. Product will be quarantined pending rework. For further questions, please call (800) 323-4035.
Quantity in commerce: 411,486 units
Distribution: Worldwide Distribution - USA Distribution
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0813-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0813-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code LRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)