Oto Med Recalls SpineX Bone Dust Collectors Due to Sterile Pouch Defects
Oto Med Inc is recalling 415 SpineX Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves packaging integrity (holes in sterile pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oto Med Inc is recalling 415 units of the Grace Medical REF S-4500 SpineX Bone Dust Collector. These devices are intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
The recall was initiated because holes were found in the sterile Tyvek pouches of the devices during internal Age Testing. This defect compromises the sterile barrier of the packaging.
The affected devices were distributed worldwide, including nationwide in the United States and in various international locations. The specific lot numbers involved are 019120 G(2), 0712119 G(2), 0912118 G(2), and 1012119 G(2). Healthcare providers should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
- Manufacturer
- Oto Med Inc
- Affected units
- 415
Distribution
Part of a larger recall action
This product is one of 3 recalled by Oto Med Inc 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 3 products in this recall →Related recalls
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