The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2246-2014·Announced 2014-08-27

Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures

Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

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 is classified as FDA Class II. The hazard involves a sterile medical device failing a leak test, which poses a risk of harm (infection or device failure) even though specific injury reports are not detailed in the source text.

Plain-English summary

Zimmer, Inc. is recalling 6.5 mm Cancellous Screws, Fully Threaded, Sterile, that failed a leak test due to damage of the inner cavity only. The affected item numbers are 47-4865-020, 025, and 030-00. A total of 47,682 units are involved in this recall.

The distribution of these medical devices was national, covering numerous U.S. states and territories, as well as foreign distribution to countries including Canada, Mexico, and various nations in Europe, Asia, and South America. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and facilities should check their inventory for the specific item numbers listed and stop using these screws. Consumers who have had these devices implanted should contact their healthcare provider for guidance.

The recalled product

Product
6.5 mm Cancellous 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 (3)

  • Item Number 47-4865-020
  • 025
  • 030-00

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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