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Grafton DBM A-Flex recallZ-0416-2012 · Osteotech Inc · initiated Aug 8, 2011

Terminated All recalls posted in January 2012

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 Osteotech 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

Aseptic conditions during the production of these products may have been compromised.

FDA root cause category: Material/Component Contamination

What the company is doing

Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.

Recall details

Recall number
Z-0416-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 8, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Osteotech Inc
Quantity
18 unts
Product code
MBP
FDA submissions
K051195
Distribution
Worldwide Distribution

Product description

Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts

Code information (models, lots, serial numbers)

Catalog Number A42160 Lot #OTSCT08 2972 Exp 4/30/14

Other devices under the same FDA submission

27 devices cleared under K051195 — 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 60263).

Sources and updates

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