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Dural Graft Matrix recallZ-1282-2013 · Integra LifeSciences Corporation · initiated Mar 28, 2013

Class II Terminated All recalls posted in May 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

FDA root cause category: Process control

What the company is doing

The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: [email protected] or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.

Recall details

Recall number
Z-1282-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 28, 2013
Posted by the FDA
May 10, 2013
Recalling firm
Integra LifeSciences Corporation
Quantity
15,607 boxes
Product code
GXQ
FDA submissions
K982180
Distribution
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Product description

Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

Code information (models, lots, serial numbers)

1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809,  1125810,  1130069, 1130061, 1130064, 1130065, 1130417,  1130521,  1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526

Other devices under the same FDA submission

5 devices cleared under K982180 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 64778).

Sources and updates

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