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Product is 2.0 cc Opteform RT. Product is labeled in part:… recallZ-0501-06 · Regeneration Technologies, Inc. · initiated Oct 14, 2005

Terminated All recalls posted in February 2006

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 Regeneration Technologies, 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

The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.

FDA root cause category: Other

What the company is doing

Notification sent to all consignees by FedEx. 10/14/2005

Recall details

Recall number
Z-0501-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 14, 2005
Posted by the FDA
Feb 7, 2006
Recalling firm
Regeneration Technologies, Inc.
Product code
MQV
FDA submissions
K043421
Distribution
Products were distributed worldwide.

Product description

Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Code information (models, lots, serial numbers)

2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 2667987 2667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 2669636 2669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985

Other devices under the same FDA submission

3 devices cleared under K043421 — 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 34004).

Sources and updates

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