Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads
Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.
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 is driven by complaints of device fracture without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 4,961 units of Trabecular Metal Tibial Impactor Replacement Pads (Item 00-5953-056-06, all lots). These pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia during orthopedic 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 addresses complaints received regarding Tibial Impactor pad fracture.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Germany, China, Canada, Australia, and Japan. Healthcare providers and facilities should refer to the clarifying instructions provided by the manufacturer to ensure proper handling of the device.
The recalled product
- Product
- Trabecular Metal Tibial Impactor Replacement Pads. 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
- 4,961
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 00-5953-056-06
- 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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