Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
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 2/5 (Moderate).
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 improve visualization and fit, without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary update.
Plain-English summary
Zimmer, Inc. is recalling the MIS 12/14 Slotted Provisional Femoral Heads, including various sizes and offsets. These medical devices are used during total hip arthroplasty to replicate final femoral implant geometry, allowing surgeons to trial range of motion, joint stability, and determine appropriate femoral head size and offset.
The recall is initiated to enhance the 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 and reduce the incidence of sub-optimal fit between provisional femoral heads and the mating components.
The recall covers 56,516 units across all lots and sizes, distributed worldwide including the USA, Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. Affected lots include all lots distributed from lot 69998600 (2/20/1996) to the present. Healthcare providers should review the updated surgical technique instructions to ensure proper use of the devices.
The recalled product
- Product
- 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14…
- Manufacturer
- Zimmer, Inc.
- 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.
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