An FDA spokesman said the agency has revoked device approvals before, although the step is rare.
ReGen, based in
Hackensack, N.J., asked the FDA in
2005 to approve its device under the so-called 510k system, which allows speedy approval for devices that are similar to products already on the market.
ReGen argued that the Menaflex was comparable to shoulder joint implants sold by Johnson & Johnson, Stryker and other companies.