Zimmer Recalls Ti-Magna Fx Washers Due to Sterile Barrier Integrity Testing
Zimmer, Inc. is recalling 2,632 Ti-Magna Fx Washers distributed in Japan to ensure sterile barrier integrity after a review of historic packaging validations.
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 a precautionary measure to verify sterile barrier integrity without reporting any specific defects, illnesses, or injuries, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 2,632 units of the Ti-Magna Fx Washer, part of the Ti-Versa-FX II Femoral Fixation System. These devices are used for the internal fixation of proximal femoral and supracondylar fractures. The washers are designed to prevent screw heads from being buried in the bone during orthopedic procedures.
The recall was initiated after Zimmer conducted a review of historic packaging validations. The company determined that a subset of product packaged at a single facility required testing to ensure that previously packaged product met established requirements for sterile barrier integrity. The source text does not specify the exact nature of the defect or confirm any specific failures, but rather indicates a need for verification of the sterile barrier.
The affected devices were distributed internationally to Japan only. The source text does not report any illnesses, injuries, or deaths associated with these devices. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 2,632
Distribution
Distribution scope not specified by the agency.
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