The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1318-2016·Announced 2016-04-13

Biomet Recalls Prelude PF Resurfacing Knee System Instrumentation for Design Control Issues

Biomet, Inc. is recalling 576 units of Prelude PF Resurfacing Knee System instrumentation due to inadequate design control. The products were distributed to 12 US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text cites 'inadequate design control' without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet, Inc. is recalling all instrumentation associated with the Prelude PF Resurfacing Knee System. The recall was initiated due to inadequate design control. The affected products include various femoral trials, drill guides, reamers, stop collars, and other surgical instruments used in knee resurfacing procedures.

A total of 576 units were distributed in the United States to the states of California, Colorado, Georgia, Indiana, Kansas, Michigan, Missouri, North Carolina, New Jersey, Ohio, Tennessee, and Texas. The recall covers all lots of all Prelude PF instrumentation part numbers.

Healthcare providers and patients should contact Biomet, Inc. for further information regarding the recall and potential replacement or repair of the affected instrumentation.

The recalled product

Product
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Instrumentation
Hazard
Affected units
576

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Left 110004248: No. 1 Femoral Trial
  • Right 110004339: No. 2 Femoral Trial
  • Left 110004250: No. 2 Femoral Trial
  • Right 110004344: No. 3 Femoral Trial
  • Left 110004252: No. 3 Femoral Trial
  • Right 110004342: No. 4 Femoral Trial
  • Left 110004254: No. 4 Femoral Trial
  • Right 110004341: No. 5 Femoral Trial
  • Left 110004256: No. 5 Femoral Trial
  • Right 110004337: No. 6 Femoral Trial
  • Left 110004258: No. 6 Femoral Trial
  • Right 110004340: No. 6W Femoral Trial
  • Left 110004260: No. 6W Femoral Trial
  • Right 110004343: No. 7W Femoral Trial
  • Left 110004262: No. 7W Femoral Trial
  • Right 110004345: No. 8W Femoral Trial
  • Left 110004264: No. 8W Femoral Trial
  • Right 110004105: No. 1 Drill Guide
  • Left 110004106: No. 1 Drill Guide
  • Right 110004107: No. 2 Drill Guide

Distribution

Distributed in 12 states:

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