Agency classClass IIOur severity:Moderate FDA (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.

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 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: leak-test-failure
inner-cavity-damage
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 →

Same manufacturer · Zimmer, Inc.

See all →

High
Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
High
Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
Moderate
Persona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01

Same hazard · leak test failure