The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2484-2012·Announced 2012-10-10

Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal 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 is classified as FDA Class II and involves reports of significant injury, specifically the intraoperative dislodging of the device and the device being left in-vivo, which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

Zimmer, Inc. is recalling specific lots of MIS 12/14 Slotted Femoral Head Provisional devices. 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 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. Some reports alleged the fit was too loose, while others alleged it was too tight. In some cases, this resulted in the intraoperative dislodging of the provisional head or the head being left in the body after separating from the mating component.

Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14…
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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