Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling 56,516 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 and involves a procedural update to surgical instructions to mitigate the risk of device displacement and sub-optimal fit, without reported injuries or fatalities.
Plain-English summary
Zimmer, Inc. is recalling 56,516 units 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 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 and reduce the incidence of sub-optimal fit between provisional femoral heads and the mating components.
The affected devices were distributed worldwide, including the USA (nationwide), Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. All lots distributed from lot 69998600 (2/20/1996) to present are included in this recall. Healthcare providers should review the updated surgical technique instructions to ensure proper device handling and location during procedures.
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…
- 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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