Agency classClass IIOur severity:Severe FDA (Devices)·Z-2479-2012·Announced 2012-10-10

Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.

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 involves a Class II medical device with reports of significant injury, specifically the intraoperative dislodging of the device and the device being left in the patient's body.

Plain-English summary

Zimmer, Inc. is recalling specific MIS 12/14 Slotted Femoral Head Provisional devices. These provisional heads are used during total hip arthroplasty to replicate final femoral implant geometry, trial range of motion, and determine appropriate size and offset.

The recall is being conducted because complaints have been 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 other cases, it was alleged to be too tight. These fit issues have led to 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 across all lots, including lot 78939000 (dated 1/7/2002) to the present. The devices were distributed nationwide in the USA and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. Healthcare providers should stop using these devices and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: device-malfunction
foreign-object-retention

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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