The Recall Desk
SevereFDA (Devices)·Z-2476-2012·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.

What this means for you

Illness, injury, or structural failure has been reported. 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 intraoperative dislodging and devices being left in-vivo, which aligns with the 'Severe' rubric criteria for Class II recalls with significant injury reports.

Plain-English summary

Zimmer, Inc. is recalling VerSys provisional femoral heads, including specific 32mm sizes and 12/14 neck tapers. The recall covers 231,641 units across all lots and sizes, distributed worldwide to the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. These devices are used during total hip arthroplasty to trial range of motion and determine appropriate implant size.

The recall was initiated after complaints reported 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 too tight. This improper fit has led to intraoperative dislodging of the provisional head and instances where the head was left in the patient's body after separating from the mating component.

Healthcare providers and patients should contact Zimmer, Inc. for instructions on how to handle the affected devices. The source text does not specify a particular action for consumers, but the recall is directed at the medical supply chain and surgical settings where these provisional implants are utilized.

The recalled product

Product
12/14 Neck Taper 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 32
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
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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Same hazard · improper fit

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