The Recall Desk
SevereFDA (Devices)·Z-2475-2012·Announced 2012-10-10

Zimmer VerSys Provisional Femoral Heads Recalled for Fit Issues

Zimmer, Inc. is recalling VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can cause 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 meets the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling VerSys and MIS provisional femoral heads used during total hip arthroplasty. 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.

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. Some reports alleged the fit was too loose, while others alleged it was too tight. This issue has resulted in intraoperative dislodging of the provisional head and instances where the provisional head was left in the patient's body after separating from the mating component.

Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for instructions on how to return or dispose of the products. Patients who have had these devices implanted should consult their healthcare provider if they have concerns about their implant.

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 Ne
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 →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · intraoperative dislodging

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