Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
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 recall of a medical device component used in orthopedic joint replacement procedures. The device qualifies as a risk-of-harm product, and no illnesses or injuries have been reported. The labeling error could potentially affect proper device identification or installation.
Plain-English summary
Limacorporate S.p.A is recalling PHYSICA HPS Tibial Liner #6 H10 (REF 6539.54.610) devices due to incorrect product labeling. A total of 33 devices with Lot/Sterilization Numbers 2122621/2200149 and 2203871/2200167 have been identified.
The affected devices were distributed in the U.S. in Arizona, California, Illinois, Louisiana, and New York.
No adverse events or injuries related to this labeling error have been reported to date. Patients who have received this device should contact their healthcare provider or Limacorporate for additional information regarding the labeling issue.
Healthcare providers and facility staff should verify the labeling on affected devices and contact Limacorporate for clarification or replacement units as needed.
The recalled product
- Product
- PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
- Manufacturer
- Limacorporate S.p.A
- Hazard
- Affected units
- 33
Distribution
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