Medline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.
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 an FDA Class II recall. The source explicitly states the health consequence is "clinically insignificant," and no actual illnesses or injuries have been reported. The hazard is a potential sterility breach with minimal clinical impact.
Plain-English summary
Medline Industries, LP is recalling Medline Kits containing Zimmer Biomet mixing bowls and spatulas (TOTAL KNEE PACK, model DYNJT6267). The kits were distributed nationwide in California and Utah. A total of 163 kits are affected, identified by UDI-DI 10198459538827 and lot numbers 26DMB644 and 26CMC467.
The kits are being recalled because the mixing bowls and spatulas contain seal nonconformities that present a risk of sterility breach. Use of the affected product could result in clinically insignificant extension of surgery time to locate another readily available device.
If you have received one of these kits, contact Medline Industries, LP for instructions on how to proceed. Do not use the affected kits.
The recalled product
- Product
- Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kit
- Affected units
- 163
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)
- UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP 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 2 products in this recall →Related recalls
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