Agency classClass IIOur severity:Severe FDA (Devices)·Z-2477-2012·Announced 2012-10-10

Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves significant injury reports, specifically the intraoperative dislodging of the device and the device being left in-vivo, which meets the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling VerSys provisional femoral heads, including specific 36mm sizes with various neck tapers. These devices are used during total hip arthroplasty to trial range of motion, joint stability, and determine appropriate femoral head size and offset.

The recall was initiated after complaints were received reporting sub-optimal fit between the provisional femoral heads and mating components, such as stems and provisional femoral necks. In some cases, the fit was alleged to be too loose, while in others, it was alleged to be too tight. This issue has resulted in intraoperative dislodging of the provisional head and instances where the head was left in the body after separating from the mating component.

The recall affects 231,641 units distributed worldwide, including the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. All lots distributed from lot 69998600 (dated February 20, 1996) to the present are included. Healthcare providers should stop using these devices and contact Zimmer, Inc. for further instructions.

The recalled product

Product: 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: device-dislodgement
foreign-object-retention
Affected units: 231,641

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.

The notice also names 1 state specifically:

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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