CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Physica HPS Tibial Liner #6 H10 recalled by Limacorporate S.p.A
Limacorporate is recalling Physica HPS Tibial Liner #6 H10, distributed in Arizona, California, Illinois, Louisiana, New York. The recall was initiated on 27 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0524-2024
- FDA event ID
- 93329
- Recalling firm
- Limacorporate, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Oct 2023
- FDA classified
- 9 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 27 Oct 2023 | Recall initiated by company | |
| 9 Dec 2023 | Classified by FDA | +43 days |
| 20 Dec 2023 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to incorrect product labeling
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Where it was distributed
U.S Distribution: AZ, CA, IL, LA, and NY
Questions about this recall
Why was it recalled?
Due to incorrect product labeling
Which lots are affected?
Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Where was it sold?
U.S Distribution: AZ, CA, IL, LA, and NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |