The Recall Desk
SevereFDA (Devices)·Z-2480-2012·Announced 2012-10-10

Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

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 provisional head being left in-vivo, which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices, including specific catalog numbers such as 00780302601 through 00780302605. 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 covers 231,641 units 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. This issue has resulted in intraoperative dislodging of the provisional head and instances where the provisional head was left in-vivo 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 given the nature of the product, the primary audience is medical professionals and patients who have undergone or are scheduled for total hip arthroplasty using these specific provisional components.

The recalled product

Product
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 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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