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INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic… recallZ-1594-2013 · Medtronic Sofamor Danek USA Inc · initiated May 28, 2013

Class II Terminated All recalls posted in June 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 Medtronic Sofamor Danek USA Inc 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

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medtronic on behalf of Integra LifeSciences Corporation sent an Urgent Voluntary Removal (Recall) letter on May 24, 2013, directly to all Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. Foreign consignees were notified by email on May 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product and discontinue use. The letter should be forwarded to surgeons or attending physicians who have used the affected products. Customers were instructed to use the attached questionnaire to account for product in their possession, document which physicians they notified and report any patient injuries that may have occurred related to the use of the affected product by calling the phone number in the questionnaire. Customers were asked to return the questionnaire using the enclosed self-addressed stamped envelope, via their Medtronic Sales Representative or via fax to 763-367-8134 For questions regarding this recall 901-399-3182. Customers were instructed to contact their Medtronic Sales Representative to coordinate the return and replenishment of affected product . Customers with questions should call 800-876-3133, ext 3197.

Recall details

Recall number
Z-1594-2013
Recall class
Class II
Status
Terminated
Initiated by the company
May 28, 2013
Posted by the FDA
Jun 25, 2013
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
400 units
Product code
NEK
FDA submissions
P000058
Distribution
Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.

Product description

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Code information (models, lots, serial numbers)

Lots: M111063AAF, M111064AAN

Other devices under the same FDA submission

30 devices cleared under P000058 — 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 65297).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page