The Recall Desk
ModerateFDA (Devices)·Z-2249-2014·Announced 2014-08-27

Zimmer Recalls 6.5 mm Cancellous Screws Due to 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.

What this means for you

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 score.

Plain-English summary

Zimmer, Inc. is recalling 6.5 mm Cancellous Screws, Fully Threaded, Sterile. The recall is being conducted because the devices failed a leak test due to damage of the inner cavity only. The affected item numbers are 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, and 100-00.

A total of 47,682 units were distributed. The distribution pattern includes national distribution across numerous US states and territories, as well as foreign distribution to countries including Canada, Mexico, Argentina, Australia, Belgium, Brazil, China, El Salvador, England, Germany, India, Italy, Japan, Jordan, Korea, New Zealand, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, and the UAE.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. The agency classification for this recall is Class II.

The recalled product

Product
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Screws
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 (14)

  • Item Number 47-4865-030
  • 035
  • 040
  • 045
  • 050
  • 055
  • 060
  • 065
  • 070
  • 075
  • 080
  • 085
  • 090
  • 100-00

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · leak test failure

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