The Recall Desk
SevereFDA (Devices)·Z-2483-2012·Announced 2012-10-10

Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

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 the device being left in-vivo, which aligns with the 'Severe' rubric criteria.

Plain-English summary

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices, including specific catalog numbers such as 00780303601 through 00780303605. These provisional heads are used during total hip arthroplasty to trial range of motion, joint stability, and determine appropriate femoral head size and offset. 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 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 other cases, it was alleged to be too tight. These fit issues have resulted in intraoperative dislodging of the provisional head and instances where the provisional head was left in the body after separating from the mating component.

Healthcare providers and patients who have used these devices should contact Zimmer, Inc. for further instructions. The source text does not specify a particular action for consumers, but the devices are intended for professional medical use during surgery.

The recalled product

Product
00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
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 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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