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U.S. Department of Health and Human Services

Class 2 Device Recall Stapler

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  Class 2 Device Recall Stapler see related information
Date Initiated by Firm February 11, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on December 30, 2015
Recall Number Z-2227-2015
Recall Event ID 71608
Product Classification Staple, implantable - Product Code GDW
Product Medical Device Exchange -SYSTEM, TACKER SKIN 5MM;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 6206;
EXP (repackager), Covidien (OEM)

Implantable Staple
Code Information OEM Catalog number 6206.
Recalling Firm/
Manufacturer		 EXP Pharmaceutical Services Corp
48021Warm Springs Boulevard
Fremont CA 94539
For Additional Information Contact Frederick R. Jorgenson, Esq.
336-770-3556
Manufacturer Reason
for Recall		 EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
FDA Determined
Cause 2		 Other
Action EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
Quantity in Commerce 3
Distribution Distributed in DC and the states of CO, CA, FL, TX, and AR.
Total Product Life Cycle TPLC 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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