Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instrume

FDA device recall Z-0752-2017 · posted 2016-12-13 · Terminated

Recall details

Recalling firm

Integra York PA, Inc

Reason for recall

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

Action taken

The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.

Root cause

Process control

Status

Terminated

Product code

LRW

Quantity affected

50 units

Distribution

US Distribution in NC and TX.

Date initiated

2016-10-28

Date posted

2016-12-13

Date terminated

2017-04-17

Location

York, PA