The Recall Desk
ModerateFDA (Devices)·Z-0395-2013·Announced 2012-11-28

Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

Zimmer, Inc. is recalling MIS Slotted Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.

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, but the source text describes an enhancement to surgical instructions to address potential difficulties in locating displaced heads and fit issues, without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary update.

Plain-English summary

Zimmer, Inc. is recalling 56,516 units of MIS 12/14 Slotted Femoral Head Provisional devices (catalog numbers 00780302201, 00780302202, and 00780302203). 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 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 enhancement also provides non-invasive imaging methods that can be used to locate the head and aims to reduce the incidence of sub-optimal fit between provisional femoral heads and the mating component.

The affected devices were distributed worldwide, including the United States (nationwide), Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. All lots distributed from lot 69998600 (February 20, 1996) to the present are included in this recall. Healthcare providers should contact Zimmer, Inc. for further instructions on the updated documentation.

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 range
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

Same manufacturer · Zimmer, Inc.

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Same hazard · displacement

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