Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0394-2013·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 the visual location of displaced heads and 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 an enhancement to surgical instructions to mitigate potential issues with locating displaced heads and fit, without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary update.

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 affects 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 for the Versys and Slotted Provisional Femoral Heads. 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 address the incidence of sub-optimal fit between the provisional femoral heads and the mating components.

Healthcare providers and facilities that have received these devices should review the updated surgical technique instructions. Users should be aware of the potential difficulty in visually locating displaced heads and utilize the recommended non-invasive imaging methods when necessary.

The recalled product

Product: 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
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 →

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