Howmedica Dall Miles SM GRIP surgical device recalled for potential package de-bonding
Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.
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: No illnesses or injuries have been reported. The hazard is a potential defect that has not yet resulted in confirmed harm. This voluntary precautionary recall for a packaging defect with no reported adverse events falls under Moderate severity.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL surgical device (Catalog Number 6704-0-110, Lot 87458602) due to a potential de-bonding of the outer Tyvek lid from the sealed package.
The outer Tyvek protective package lid may separate from the unit. This could compromise the integrity of the sealed package.
The product was distributed worldwide to the United States, Puerto Rico, Canada, and Malaysia. Patients and healthcare providers should verify package integrity before use. If the protective seal appears compromised, do not use the device and contact Howmedica Osteonics Corp. for further instructions or return of affected units.
The recalled product
- Product
- Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 1
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)
- UDI: 07613327013306
- Lot Number: 87458602
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. 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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