Zimmer Biomet Recalls Fitmore Hip Stems Due to Packaging Adhesion
Zimmer Biomet is recalling Fitmore Hip Stems because non-highly polished implants may adhere to the LDPE bag used in previous packaging configurations.
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 the hazard involves a packaging defect (adhesion to the bag) rather than a direct structural failure or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling Fitmore Hip Stems, a type of hip prosthesis, due to a packaging issue. The recall covers various sizes of the device, identified by specific item numbers, with a total of 5,459,583 devices affected. All products included in this recall were manufactured prior to January 2014 and were distributed nationwide.
The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was part of the previous packaging configuration. This adhesion could potentially interfere with the handling or inspection of the implant prior to surgical use.
Healthcare providers and facilities that have received these devices should contact Zimmer Biomet for further instructions on how to manage the affected inventory. Consumers who have had these implants placed in their bodies should consult with their healthcare provider if they have concerns regarding the recall.
The recalled product
- Product
- Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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 product manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, 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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