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U.S. Department of Health and Human Services

Class 2 Device Recall MYO/Punch; A&E Surgical Punch

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 Class 2 Device Recall MYO/Punch; A&E Surgical Punchsee related information
Date Initiated by FirmOctober 23, 2017
Create DateMarch 01, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall NumberZ-0813-2018
Recall Event ID 79274
Product Classification Punch, surgical - Product Code LRY
ProductSurgical 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.
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)
Recalling Firm/
Manufacturer		 Alto Development Corp
5206 Asbury Rd
Wall Township NJ 07727-3609
Manufacturer Reason
for Recall		Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
FDA Determined
Cause 2		Package design/selection
ActionA&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 Commerce411,486 units
DistributionWorldwide Distribution - USA Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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