The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2248-2014·Announced 2014-08-27

Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous 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 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 score.

Plain-English summary

Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws with a 32 mm thread length. The recall was initiated because the devices failed a leak test due to damage of the inner cavity only.

The affected products are sterile and were distributed nationally across the United States, including all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. The products were also distributed internationally 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.

Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement. Consumers are not expected to have these medical devices in their possession.

The recalled product

Product
6.5 mm Cancellous Screw 32 mm Thread Length 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 (11)

  • Item Number 47-4865-045
  • 050
  • 055
  • 060
  • 065
  • 070
  • 075
  • 080
  • 085
  • 090
  • 100-02

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.

See all →

Same hazard · leak test failure

See all →

Similar recalls