The Recall Desk
HighFDA (Devices)·Z-0314-2022·Announced 2021-12-08

Orthopedic Implant Head Package Lid May Debond From Sealed Package

Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.

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 a Class II medical device recall involving potential package integrity failure on an orthopedic implant. While no illnesses or injuries have been reported, the defect poses a risk of harm through potential sterility compromise.

Plain-English summary

Howmedica Osteonics Corp. is recalling the 28MM -4 LFIT V40 HEAD (Catalog Number 6260-9-122), an orthopedic implant component. The outer white Tyvek lid of the sealed package may debond, potentially compromising package integrity.

The affected lot numbers are 86604305 and 86604306. The product was distributed in Puerto Rico. The UDI number is (01) 07613327013016(17)261013(10).

No illnesses or injuries have been reported. This is a Class II medical device recall. Patients and healthcare providers with affected units should contact Howmedica Osteonics Corp. for further information.

The recalled product

Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implants
Hazard
  • lid-debonding
  • package-integrity

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 (3)

  • UDI number - (01) 07613327013016(17)261013(10)
  • lot numbers - 86604305
  • 86604306

Distribution

Distribution scope not specified by the agency.

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