Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0997-2019·Announced 2019-03-20

Ossur Skull Pin Recall Due to Labeling Error and Safety Testing

Ossur Americas is recalling 372 sterile titanium skull pins because the label incorrectly lists a ceramic tip and the products require confirmatory 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 labeling error and the need for confirmatory testing, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ossur Americas is recalling 372 units of Ossur Skull Pins, sterile titanium pins, due to a labeling error and the need for confirmatory safety testing. The second line of the description on the titanium pin label mistakenly lists 'ceramic tip' instead of 'titanium pin.'

The recall covers all lots of the products manufactured between June 30, 2009, and December 13, 2018. Specific part and lot numbers include 516TS (AL18021418 and AL17022109) and 520TS (AL18021417 and AL15091012). The affected products were distributed in 30 U.S. states and in Australia, Germany, New Zealand, and Belgium.

Halo system products labeled as MR conditional will undergo confirmatory safety testing to verify MR conditional parameters. The FDA has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected products and contact Ossur Americas for further instructions.

The recalled product

Product: Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
Manufacturer: Ossur Americas
Category: Medical Device — Orthopedic / Neurosurgical
Hazard: mis-labeling
safety-testing
Affected units: 372

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)

Part/Lot numbers: 516TS/ AL18021418 and AL17022109
520TS/ AL18021417 and AL15091012

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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