Agency classClass IIOur severity:Severe FDA (Devices)·Z-2481-2012·Announced 2012-10-10

Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead 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 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 MIS 12/14 Slotted Femoral Head Provisional components (catalog numbers 00780302801 through 00780302805 and 00780302814) and VerSys provisional femoral heads. The recall covers 231,641 units across all lots and sizes, distributed worldwide including the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.

The recall was initiated after complaints were received reporting sub-optimal fit between the provisional femoral heads and their 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 the 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.

These devices are used during total hip arthroplasty to trial range of motion, joint stability, and determine appropriate femoral head size and offset. Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions on replacement or return.

The recalled product

Product: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: device-malfunction
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 including lot 78939000 (1/7/2002) 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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