Zimmer Biomet Recalls Modular Hybrid Glenoid Base for Quality Issues
Zimmer Biomet is voluntarily recalling 16 units of the Modular Hybrid Glenoid Base Large after two pieces with quality defects were shipped.
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: This is a voluntary precautionary recall for a Class II medical device where the hazard is limited to specific quality defects (scratches and non-conforming threads) on a small number of units, with no reported injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is conducting a voluntary recall of 16 units of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System. The recall involves a single lot (Lot Number: 270260) of the product, which is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty.
The recall was initiated after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece had scratches and the other had non-conforming threads.
The affected units were distributed worldwide, including in the United States (OH, AZ, ID, PA, AR, MN, IL, CA, MD, NY) and Canada. Consumers and healthcare providers should check their inventory for the specific model number 113956 and lot number 270260. If the product is found, it should be removed from use and the recalling firm contacted for instructions.
The recalled product
- Product
- Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 16
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 (5)
- Model Number: 113956
- Modular Hybrid Glenoid Base Large
- Item Number: 113956
- Lot Number: 270260
- UDI Number: (01) 00880304462618 (17) 211204 (10) 270260
Distribution
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