NeuraWrap Nerve Protector recallZ-1286-2013 · Integra LifeSciences Corporation · initiated Mar 28, 2013

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-1286-2013

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

954 boxes

Product code

JXI

FDA submissions

K041620, K072207

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

NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Other devices under the same FDA submission

2 devices cleared under K041620, K072207 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NeuraWrap® NW1040

  Integra Lifesciences Corporation · CUFF, NERVE
  2 reports
• NeuraWrap® NW1020

  Integra Lifesciences Corporation · CUFF, NERVE
  1 report

Other products in the same recall event

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

• Z-1282-2013 · Terminated
  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 …
• Z-1283-2013 · Terminated
  Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handl…
• Z-1284-2013 · Terminated
  DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the…
• Z-1287-2013 · Terminated
  NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.