Stryker Surgical Burs Recalled Due to Package Label Mismatch
Stryker Corporation is recalling surgical burs that may be packaged with incorrect labels, causing a mismatch between the device model inside and the label. Approximately 491 affected devices were distributed worldwide.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling and packaging identification issue where the device inside may not match its outer label, rather than a defect in the surgical instruments themselves.
Plain-English summary
Stryker Corporation is recalling two models of surgical burs: the 3.0MM Neuro Match Head Soft Touch bur (model 5820-107-030) and the 3.0MM Prec Neuro Match Head bur (model 5820-107-530). These burs are single-use surgical instruments intended for cutting bone and bone cement during neurosurgery, spinal surgery, orthopedic surgery, ear-nose-throat procedures, and maxillofacial surgery.
The recall affects approximately 491 devices because the device inside the package may not match the product information on the outer label. For example, a package labeled 5820-107-030 may contain a 5820-107-530 device instead.
The affected devices were distributed worldwide, including throughout the United States and to Colombia, Sweden, the Netherlands, and the United Kingdom. The affected lot number is 21341057 (GTIN 04546540362483).
If you have received these devices, verify that the actual device model matches the label on the package before use. Contact Stryker Corporation or your supplier if the device and label do not match.
The recalled product
- Product
- The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgic
- Manufacturer
- Stryker Corporation
- Affected units
- 491
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)
- GTIN 04546540362483
- Lot Number 21341057
Distribution
Distributed nationwide across the United States.
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