Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0999-2019·Announced 2019-03-20

Ossur OB Resolve Sterile Ring Kits Recalled for Labeling Errors

Ossur Americas is recalling 342 units of OB Resolve sterile ring kits due to a labeling error on titanium pins and pending safety testing.

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 involves minor labeling errors and pending safety testing, which aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures.

Plain-English summary

Ossur Americas is recalling 342 units of Ossur OB Resolve, Sterile, ring kits and component trays. The recall covers all lots of these products manufactured between June 30, 2009, and December 13, 2018. The affected products were distributed to various states in the United States, including Hawaii, Alabama, California, and Washington, as well as to foreign countries such as Australia, Germany, New Zealand, and Belgium.

The recall was initiated because Halo system products labeled as MR conditional require confirmatory safety testing to verify their MR conditional parameters. Additionally, a labeling error was identified on the titanium pins, where the second line of the description incorrectly lists a ceramic tip instead of a titanium pin.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected products and contact Ossur Americas for further instructions regarding the return or replacement of the items.

The recalled product

Product: Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No…
Manufacturer: Ossur Americas
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
safety-testing
Affected units: 342

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 lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 8 recalled by Ossur Americas 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 8 products in this recall →

Same manufacturer · Ossur Americas

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