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[Enforcement] Biomet, Inc. — All instrumentation associated with the Prelude PF Resurfaci

Apr 13, 2016
Published: 2016-04-13Captured: 2026-02-09Biomet, Inc.Product: All instrumentation associated with the Prelude PF Resurfacing Knee System.

FDA issued a Class II enforcement action. Affects Biomet, Inc.. Reason: Inadequate design control..

  • •Classification: Class II
  • •Firm: Biomet, Inc.
  • •Status: Terminated
  • •Distribution: US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
Reason:Inadequate design control.
Status:Terminated
Distribution

US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

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All instrumentation associated with the Prelude PF Resurfacing Knee System. | TrueMedDevice