Lucero Medical Recalls Enduramesh Spacers Due to Sterilization Validation Failure
Lucero Medical LLC is voluntarily recalling 169 Enduramesh Corpectomy Spacer Systems because the sterilization recommendations on the product insert did not pass sterilization validation.
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 is a voluntary precautionary recall based on a documentation/validation issue (sterilization recommendations) with no reported illnesses or injuries, fitting the Moderate criteria.
Plain-English summary
Lucero Medical LLC is voluntarily recalling 169 units of the Enduramesh Corpectomy Spacer System. The device is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The recall was initiated after the firm discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
The affected units were distributed nationwide in the United States. The recall covers specific part and lot numbers, including 762.010L-110738, 762.013L-110738, and various lots for part numbers 762.017L through 762.790L. The source text does not specify the exact dates of distribution or the specific facilities where the devices were implanted.
Healthcare providers and patients should contact Lucero Medical LLC for further instructions regarding the return or replacement of these devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is…
- Manufacturer
- Lucero Medical LLC
- Affected units
- 169
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 (20)
- Part #-Lot # (s): 762.010L-110738
- 762.013L-110738
- 762.017L-60611
- 90611
- and 512171
- 762.019L-60611
- 100308
- 1261901
- and 20121901
- 762.021L-60611
- 110106
- 20122101
- and 20122102
- 762.023L- 90611
- 100209
- 100218
- 00706
- 10709
- 20122301
- and 20122302
Distribution
Distributed nationwide across the United States.
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