The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1522-2018·Announced 2018-05-02

Zimmer Biomet Recalls Orthopedic Salvage System Locking Collars

Zimmer Biomet is recalling Orthopedic Salvage System locking collars due to a potential dry blast irregularity on the screws.

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, and the source text describes a potential manufacturing irregularity without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling the Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600. The recall involves 16 units associated with Lot Numbers 360610 and 333020. The product is used for the replacement of segmental defects of long bone and arthrodesis of the knee.

The recall was initiated because there is a potential dry blast irregularity on the locking collar screws packaged with the locking collar. The product was distributed to the states of Connecticut, Florida, Georgia, Indiana, Massachusetts, Michigan, New York, and Texas, as well as to Malaysia and the Netherlands.

Healthcare providers and patients should contact Zimmer Biomet for further information regarding the recall and potential replacement or repair options.

The recalled product

Product
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

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)

  • Lot Number 360610
  • 333020

Distribution

Distributed in 8 states:

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