The Recall Desk
HighFDA (Devices)·Z-0644-2022·Announced 2022-02-23

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.

What this means for you

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
  • de-bonding

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

Distribution scope not specified by the agency.

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