CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

Scorpio U-dome Patella -Intended for knee replacement recalled

Howmedica Osteonics is recalling Scorpio U-dome Patella -Intended for knee replacement, distributed nationwide in the US. The recall was initiated on 1 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 07613327033892 Lot Numbers: RDWN, 4W3T, V768, VJ05, TWT6, ADK0, 855, D6D9, TXL1, 53RN, KR24, M3T4, VE90, EKK2, 36L1, NH6E, 8PWK, R9A4, NWXA, D47L, 5JVL, D16P, E2LP, 927H, JR5N
Quantity recalled149 units US; 424 units OUS

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-0896-2024
FDA event ID
93687
Recalling firm
Howmedica Osteonics, Mahwah, NJ
Classification
Class II
Status
Ongoing
Recall initiated
1 Dec 2023
FDA classified
31 Jan 2024
Reported
7 Feb 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

1 Dec 2023Recall initiated by company
31 Jan 2024Classified by FDA+61 days
7 Feb 2024Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Product as listed by the FDA

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708

Where it was distributed

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

Nationwide

Questions about this recall

Why was it recalled?

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Which lots are affected?

GTIN: 07613327033892 Lot Numbers: RDWN, 4W3T, V768, VJ05, TWT6, ADK0, 855, D6D9, TXL1, 53RN, KR24, M3T4, VE90, EKK2, 36L1, NH6E, 8PWK, R9A4, NWXA, D47L, 5JVL, D16P, E2LP, 927H, JR5N

Where was it sold?

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

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.

Other products in this recall event

57 other products · FDA event 93687

This product is part of a recall event; the main page for the event is Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIPrimary Rev.Tib.Insert-duracon Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIPS Lipped Tibial Insert Assy Duracon Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Medialized Dome Patella-sz #11 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IILeft Small-pca Mod.Rev.Dur.Rev.Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio U-dome Patella -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Concentric Dome Patella-sz #9 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Concentric Dome Patella-sz #7 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio U-dome Patella -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIDuration A-p Lipped Tib.Insert-durac Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Recessed Patella- Intended for Knee Replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Recessed Patella- Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Recessed Patella-Intended for knee repalcment recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IILeft Small-pca Mod.Rev.Dur.Rev.Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Recessed Patella- Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIDUR PCA MTK REV INS LFT Intended recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
CLASS IITrident 0 deg Poly Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Medialized Dome Patella-sz #7 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Medialized Dome Patella-sz #9 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIDUR PCA MTK REV INS LFT Intended recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
CLASS IIScorpio U-dome Patella -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IITibial Bearing Insert Series P-s I Assy Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIPS Lipped Tibial Insert Assy Duracon Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIPS Lipped Tibial Insert Assy Duracon Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIDUR PCA MTK REV INS RT Intended recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
CLASS IITrident 0 deg Poly Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIP7 10 Degree + Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIRgt.Large-pca Mod.Rev.- Dur.Rev.Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IISeries II Tibial Bear Insert-Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IILeft Large-pca Mod.Rev.Dur.Rev.Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IILeft X-large-pca Mod.Rev.Dur.Rev.Insert Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIP7 1O Degree + Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Concentric Dome Patella-sz #11 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIDuration Plastic Patella-duracon Intended recalledHowmedica OsteonicsForeign MaterialNationwide
CLASS IIScorpio TS Tib Insert-Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIRgt.Large-pca Mod.Rev.- Dur.Rev.Insert Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIDUR PCA MTK REV INS RT Intended recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
CLASS IIScorpio U-dome Patella -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIRgt.Large-pca Mod.Rev.- Dur.Rev.Insert Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IILeft Large-pca Mod.Rev.Dur.Rev.Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IISeries II Tibial Bear Insert-Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Total Knee Medialized Dome Patella-sz #5 -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio Ts Tib Insert recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
CLASS IIScorpio TS Tib Insert -Intended for knee replacment recalledHowmedica OsteonicsOtherNationwide
CLASS IILarge Primary Rev.Tib.Insert- Duracon Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IITrident 0 deg Poly Insert Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio U-dome Patella -Intended for knee replacement recalledHowmedica OsteonicsOtherNationwide
CLASS IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended recalledHowmedica OsteonicsOtherNationwide
CLASS IIDuration A-p Lipped Tib.Insert-durac Intended recalledHowmedica OsteonicsOtherNationwide

More recalls from Howmedica Osteonics

All 232
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IITri Ts Baseplate Size recalled by Howmedica OsteonicsHowmedica OsteonicsPackaging DefectsNationwide
DeviceCLASS IITri Ts Baseplate Size recalled by Howmedica OsteonicsHowmedica OsteonicsPackaging DefectsNationwide
DeviceCLASS IIMICS3 Angled Sagittal Saw Attachment recalled by Howmedica OsteonicsHowmedica OsteonicsOtherNationwide
DeviceCLASS IIThe Stryker CranialMask Tracker is a single-use device recalledHowmedica OsteonicsDevice MalfunctionNationwide
DeviceCLASS IIExeter V40 Stem No recalled by Howmedica OsteonicsHowmedica OsteonicsPackaging DefectsNJ

Other Hip & Knee Implants recalls

All 3,097
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline convenience kits labeled as: Femoral Pack, Medline Kit recalledMedline IndustriesOtherNationwide
DeviceCLASS IIArvis Surgical Navigation System Gen recalled by Kico Knee InnovationKico Knee InnovationDevice Malfunction19 states
DeviceCLASS IIVeritas Standard Reverse Total Shoulder Veritas Standard recalledrestor3dDevice MalfunctionNationwide
DeviceCLASS IIEndo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalledWaldemar Link GmbH & Co. KG (Mfg Site)OtherIN
DeviceCLASS IIU2 Total Knee System Femoral offset bushing recalledUnited OrthopedicDevice MalfunctionNationwide