The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2244-2014·Announced 2014-08-27

Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures

Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.

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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling 47,682 units of the Magna-Fx Cannulated Screw Fixation System, specifically the fully threaded sterile bone screws. The recall was initiated because the affected devices failed a leak test, which was attributed to damage of the inner cavity only.

The affected products are identified by Item Numbers 00-1146-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, and -99. These devices were distributed nationally across the United States and internationally to countries including Canada, Mexico, and various locations in Europe, Asia, and the Middle East.

Healthcare providers and facilities should check their inventory for these specific item numbers and stop using the affected units. Consumers are not expected to have these medical devices in their possession, as they are intended for professional medical use.

The recalled product

Product
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
47,682

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 (15)

  • Item Number 00-1146-030
  • 035
  • 040
  • 045
  • 050
  • 055
  • 060
  • 065
  • 070
  • 075
  • 080
  • 085
  • 090
  • 095
  • -99

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 8 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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