Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0392-2013·Announced 2012-11-28

Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.

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, but the source text describes a procedural update to instructions rather than a defect causing reported injuries or illnesses, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling VerSys Provisional Femoral Heads, which are used during total hip arthroplasty to trial range of motion and determine implant size. The recall involves 128,946 units across all lots and sizes, distributed worldwide including the United States, Canada, Europe, and other regions.

The recall is initiated to enhance surgical technique instructions. The updated instructions inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon. The instructions also provide non-invasive imaging methods that can be used to locate the head and aim to reduce the incidence of sub-optimal fit between the provisional femoral heads and the mating components.

Healthcare providers who have used or have these devices in inventory should review the updated surgical technique instructions. Consumers are not directly affected as these are surgical implants used by professionals.

The recalled product

Product: 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
surgical-complication
Affected units: 128,946

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 (1)

All lots distributed from lot 69998600 (2/20/1996) to present

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 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 · mis labeling