Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads 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 instructions to mitigate the risk of a device becoming difficult to locate, which aligns with the criteria for moderate severity involving low-risk procedural adjustments.
Plain-English summary
Zimmer, Inc. is recalling 56,516 units of MIS 12/14 Slotted Provisional Femoral Heads, including various offsets 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 and reduce the incidence of sub-optimal fit between provisional femoral heads and the mating components.
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. Healthcare providers should review the enhanced instructions and use the provided imaging methods to locate displaced heads.
The recalled product
- Product
- 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
- 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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