Orthopedic implant hip component recalled in Puerto Rico
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
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: This is a Class II medical device recall with no reported illnesses, injuries, or hospitalizations documented in the source text. The specific hazard or defect is not specified. FDA Class II recalls without documented harm or known hazard details, particularly when voluntary and precautionary in nature, warrant a Moderate severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling the 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028, a medical device component used in orthopedic surgery. The affected lot numbers are 86953401 and 86953503.
The FDA has classified this as a Class II recall. The specific reason or hazard associated with this recall has not been provided in this notice.
The product was distributed to Puerto Rico. Patients and healthcare providers who have received or implanted this device should contact the recalling firm for further information and guidance regarding this ongoing recall.
For additional information, contact Howmedica Osteonics Corp. at 325 Corporate Drive, Mahwah, NJ 07430-2006. The recall was initiated on October 15, 2021, and remains ongoing.
The recalled product
- Product
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
- 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) 07613327012996(17)261913(10)
- lot numbers - 86953401
- 86953503
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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