The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2245-2014·Announced 2014-08-27

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

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

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (leak test failure) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Zimmer, Inc. is recalling 47,682 units of the Magna-Fx Cannulated Screw Fixation System, specifically the Cannulated Bone Screw (Sterile). The recall was initiated because the affected screws failed a leak test due to damage of the inner cavity only.

The affected products are identified by Item Numbers 00-1146-040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, and 100-32. 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 stop using the affected screws and contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw 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 (13)

  • Item Number 00-1146-040
  • 045
  • 050
  • 055
  • 060
  • 065
  • 070
  • 075
  • 080
  • 085
  • 090
  • 095
  • 100-32

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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