Agency classClass IIOur severity:Severe FDA (Devices)·Z-2478-2012·Announced 2012-10-10

Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to 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 intraoperative dislodging and components being left in-vivo, which meets the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 231,641 units of VerSys provisional femoral heads, including specific 40mm sizes and 12/14 neck tapers. These medical 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 too tight. These fit issues have resulted in intraoperative dislodging of the provisional head and instances where the head was left in-vivo after separating from the mating component.

The affected products were distributed worldwide, including nationwide in the USA and internationally to 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 in this recall. Healthcare providers should stop using these devices and contact Zimmer, Inc. for further instructions.

The recalled product

Product: 12/14 Neck Taper 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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: improper-fit
intraoperative-dislodging
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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Same hazard · improper fit