Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0391-2013·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.

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 involves a procedural update to reduce the risk of sub-optimal fit and difficulty locating displaced heads, which aligns with the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injuries.

Plain-English summary

Zimmer, Inc. is recalling VerSys Provisional Femoral Heads, including specific 28mm sizes with various offsets, to enhance surgical technique instructions. The recall covers 128,946 units across all lots and sizes, distributed worldwide including the United States, Canada, Europe, and other regions.

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

Healthcare providers who have used these devices should review the enhanced surgical technique instructions. The recall affects all lots distributed from lot 69998600 (dated 2/20/1996) to the present.

The recalled product

Product: . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14…
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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