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 and involves a procedural update to surgical instructions to mitigate the risk of a displaced implant, which aligns with the rubric for moderate severity.
Plain-English summary
Zimmer, Inc. is recalling 56,516 units of MIS 12/14 Slotted Provisional Femoral Heads, including all lots and sizes. 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.
The affected products were distributed worldwide, including the United States, Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. All lots distributed from lot 69998600 (2/20/1996) to the present are included in this recall.
The recalled product
- Product
- 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 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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