Ossur Skull Pin Recall for Labeling Error and Safety Testing
Ossur Americas is recalling 824 sterile skull pins due to a label error 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, but the primary issue is a minor labeling error and pending safety testing without reported injuries, fitting the 'Moderate' criteria for minor labeling errors or voluntary precautionary measures.
Plain-English summary
Ossur Americas is recalling 824 units of Ossur Skull Pins, specifically sterile ceramic tip pins, due to a labeling error and the need for confirmatory safety testing. The affected products include various part numbers such as 516CS, 516DS, 517CS, 517DS, 522CS, and 522C, manufactured between June 30, 2009, and December 13, 2018.
The recall was initiated because the second line of the description on the titanium pin label mistakenly lists 'ceramic tip' instead of 'titanium pin.' Additionally, Halo system products labeled as MR conditional are undergoing confirmatory safety testing to verify their MR conditional parameters. The products were distributed across numerous U.S. states and in Australia, Germany, New Zealand, and Belgium.
Healthcare facilities and consumers should stop using the affected pins and contact Ossur Americas for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN…
- Manufacturer
- Ossur Americas
- Affected units
- 824
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
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.
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