Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints
Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.
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 indicates the action is to provide clarifying instructions due to complaints of fracture, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Zimmer, Inc. is recalling 1,165 units of Trabecular Metal Tibial Impactor Pads (Item 00-5953-056-00, all lots). These pads are used in conjunction with the Trabecular Metal Tibial Impactor to impact the tibial tray onto the tibia during surgical procedures.
The recall was initiated to provide clarifying instructions regarding the assembly and disassembly of the Trabecular Metal Tibial Impactor with and from the TM Tibial Impactor Pads. This action follows complaints regarding Tibial Impactor pad fracture.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text does not specify specific actions for consumers or patients beyond the manufacturer's provision of clarifying instructions.
The recalled product
- Product
- Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,165
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 (2)
- Item 00-5953-056-00
- all lots
Distribution
Part of a larger recall action
This product is one of 2 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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