Howmedica Osteonics Medical Device Packaging Defect: Tyvek Lid De-bonding Recall
Howmedica Osteonics is recalling medical devices because the outer Tyvek lid may separate from the package seal. This affects 32MM -4 V40 TAPER VIT HEAD devices distributed worldwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with no reported illnesses or injuries. The package defect poses a risk of device contamination if the seal fails, fitting the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 32MM -4 V40 TAPER VIT HEAD devices (Catalog Number 6260-5-032) due to a potential packaging defect. The outer Tyvek lid may de-bond from the sealed package.
The recall affects 8 units that were distributed worldwide to the United States, Puerto Rico, Canada, and Malaysia. The affected lot number is 87327407.
The recalled product
- Product
- 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device
- Hazard
- Affected units
- 8
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: 07613327012842
- Lot Number: 87327407
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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