Zimmer Universal Locking System Recalled for Incorrect Silk Screening
Zimmer, Inc. is recalling 18 units of the Universal Locking System due to incorrect catalog numbers printed on the trays.
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 describes a labeling error (incorrect silk screening) without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Zimmer, Inc. is recalling 18 units of the Zimmer Universal Locking System, Titanium 3.5mm. The recall was initiated after a review of open complaints and stock investigations revealed that a single lot of the product has incorrect silk screening applied by the supplier.
The specific defect involves the T-plate catalog numbers listed on the trays. The trays are incorrectly labeled with the 00-4946-xxx-xx series, which corresponds to titanium plates, whereas the correct numbers for the stainless steel plates should be 00-4936-xxx-xx. The affected product is identified by Item No. 00-4836-080-00 and Lot 56555128.
The affected units were distributed in North Carolina, Alabama, Kansas, Texas, Utah, California, and Singapore. Consumers and healthcare facilities should stop using the affected trays and contact Zimmer, Inc. for instructions on how to proceed.
The recalled product
- Product
- Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 18
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 (2)
- Item No. 00-4836-080-00
- Lot 56555128
Distribution
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