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.
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 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.
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
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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