Zimmer Biomet Recalls Periarticular Femur Plates Due to Packaging Adhesion
Zimmer Biomet is recalling 5,459,583 periarticular femur plates because non-highly polished implants may adhere to the LDPE bag packaging.
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: The recall is classified as FDA Class II, and the hazard involves a packaging interaction (adhesion) rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,459,583 units of PERIARTICULAR PLATES - FEMUR. The affected devices are identified by specific item numbers and were manufactured prior to January 2014. These medical devices were distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration for these products. This issue is related to the interaction between the implant surface and the packaging material.
Consumers and healthcare providers should check their inventory for these specific item numbers and stop using the affected devices. Zimmer Biomet is the recalling firm responsible for this action.
The recalled product
- Product
- PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 002347
- 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.
See all 41 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging adhesion
See all →- ModerateZimmer Biomet Recalls Tibia Lock Plates Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- HighZimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls CLS Brevius Stem Kinectiv Hip Prostheses
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Limb Salvage Arthroplasty Devices Due to Packaging Issue
FDA (Devices) · 2019-11-13