Zimmer Biomet Recalls Periarticular Elbow and Humeral Plates
Zimmer Biomet is recalling specific periarticular plates because non-highly polished implants may adhere to the packaging bag.
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/adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific lots of Periarticulare Plates, including Elbow, Humeral, and Ulna Plates. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all items manufactured prior to January 2014.
The recall is being issued because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration for these devices. This issue could potentially affect the handling or deployment of the implants during surgical procedures.
Healthcare providers and facilities that have received these specific item numbers should check their inventory for the affected lots. Patients who have had these implants placed should contact their healthcare provider for guidance regarding the recall.
The recalled product
- Product
- Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 002348
- 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