Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys 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: This is an FDA Class II recall involving a procedural update to surgical instructions to mitigate the risk of a device becoming difficult to locate, without reported injuries or fatalities.
Plain-English summary
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads, including specific 36mm sizes with various offsets. 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 instructions also provide non-invasive imaging methods that can be used to locate the head.
The recall covers 128,946 units across all lots and sizes, distributed worldwide including the USA, Asia, Canada, Europe, and other regions. All lots distributed from lot 69998600 (2/20/1996) to present are affected. Healthcare providers should review the updated surgical technique instructions to ensure proper identification and management of displaced provisional heads.
The recalled product
- Product
- . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14
- Manufacturer
- Zimmer, Inc.
- Affected units
- 128,946
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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FDA (Devices) · 2012-11-28
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