The Recall Desk
ModerateFDA (Devices)·Z-0398-2013·Announced 2012-11-28

Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices to update surgical instructions regarding the visual location of displaced heads.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a procedural update to surgical instructions to mitigate the risk of sub-optimal fit and difficulty locating displaced heads, which aligns with the criteria for moderate severity.

Plain-English summary

Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices, including various sizes and offsets. These provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. The recall covers 56,516 units across all lots and sizes, distributed worldwide to the USA, Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.

The recall is initiated to enhance surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. The updated instructions inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon. The instructions also provide non-invasive imaging methods that can be used to locate the head. The goal is to reduce the incidence of sub-optimal fit between provisional femoral heads and the mating components.

Healthcare providers and facilities that have received these devices should review the updated surgical technique instructions. Users should be aware of the potential for the head to become displaced and utilize the recommended non-invasive imaging methods for location if necessary.

The recalled product

Product
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
56,516

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 distributed from lot 69998600 (2/20/1996) to present

Distribution

Distributed nationwide across the United States.

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 →

Related recalls

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Same hazard · displacement

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