Encore Medical, LP

FDA Regulatory Profile

Encore Medical, LP has 99 FDA recalls, 10 inspections, 85 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Encore Medical, LP" and its spelling variants "Encore Medical", "Encore Medical L.P", "Encore Medical, L.P", "Encore Medical Corporation".

Latest recall
Z-2701-2026 · Class II · Feb 16, 2026
Latest inspection
Oct 28, 2021 · VAI
Latest 510(k)
Oct 2, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls99Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances85Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Encore Medical, LP's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Encore Medical, LP: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 2 inspections220212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600070
2025000140
202400020
2023000160
202200040
202120040
202010070
201900020
2018000110
2017000170

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

99 recall records from Jul 16, 2012 to Feb 16, 2026. Showing the 20 most recent. View all 99 recall records

NumberClassProductDate
Z-2701-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number…Feb 16, 2026
Z-2700-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number…Feb 16, 2026
Z-1458-2026Class IIBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM…Jan 15, 2026
Z-1460-2026Class IIBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT…Jan 15, 2026
Z-1459-2026Class IIBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number…Jan 15, 2026
Z-1233-2026Class IIEMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705Jan 5, 2026
Z-1234-2026Class IIEMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree…Jan 5, 2026
Z-2548-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog…Jul 18, 2025
Z-2547-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm…Jul 18, 2025
Z-2546-2025Class IIBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog…Jul 18, 2025
Z-2549-2025Class IIBrand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None…Jul 18, 2025
Z-2286-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE…Jul 9, 2025
Z-2285-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE…Jul 9, 2025
Z-2147-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing…Jun 12, 2025
Z-2148-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing…Jun 12, 2025
Z-2126-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE…Jun 2, 2025
Z-2125-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE…Jun 2, 2025
Z-2008-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm…May 28, 2025
Z-2009-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm…May 28, 2025
Z-2011-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm…May 28, 2025

Recent FDA inspections

10 inspections from Jul 9, 2009 to Oct 28, 2021.

DateSiteProductClassificationFEI
Oct 28, 2021Austin, TXDevicesVoluntary Action Indicated (VAI)1000116912
Jul 20, 2021Cedar Park, TXDevicesVoluntary Action Indicated (VAI)3043011229
Mar 11, 2020Austin, TXDevicesNo Action Indicated (NAI)1000116912
May 2, 2016Saint Paul, MNDevicesVoluntary Action Indicated (VAI)3003215458
Jul 24, 2015Austin, TXDevicesNo Action Indicated (NAI)1000116912
Jun 28, 2013Austin, TXDevicesNo Action Indicated (NAI)1000116912
Dec 19, 2012Saint Paul, MNDevicesNo Action Indicated (NAI)3003215458
May 18, 2011Saint Paul, MNDevicesVoluntary Action Indicated (VAI)3003215458
Oct 21, 2009Austin, TXDevicesVoluntary Action Indicated (VAI)1000116912
Jul 9, 2009Hixson, TNDevicesNo Action Indicated (NAI)1022819
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000116912Austin, TX5Oct 28, 2021
FEI 3043011229Cedar Park, TX1Jul 20, 2021
FEI 3003215458Saint Paul, MN3May 2, 2016
FEI 1022819Hixson, TN1Jul 9, 2009

Recent 510(k) clearances

85 510(k) clearances from Aug 23, 2002 to Oct 2, 2026. Showing the 20 most recent. View all 85 510(k) clearances

K-NumberDeviceDate
K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyOct 2, 2026
K252567AltiVate Reverse® ADLC GlenosphereJan 15, 2026
K252974EMPOWR KneeDec 19, 2025
K251833EMPOWR Acetabular® Liner ExtensionNov 12, 2025
K252141AltiVate Reverse® GlenoidAug 5, 2025
K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Jul 8, 2025
K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Jul 2, 2025
K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System…May 16, 2025
K241483ceramys™ femoral head systemFeb 7, 2025
K233481AltiVate Reverse® GlenoidMay 29, 2024
K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersJun 23, 2023
K223779EMPOWR™ blade stemFeb 13, 2023
K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersJul 7, 2022
K213793EMPOWR Revision KneeApr 1, 2022
K210308EMPOWR Porous Femur with HAnano SurfaceTMMar 30, 2021
K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingFeb 10, 2021
K203026AltiVate® Anatomic Pegged Glenoid with MarkersDec 23, 2020
K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderJun 3, 2020
K191325EMPOWR Partial KneeJul 16, 2019
K190057DJO Acetabular SystemJun 7, 2019

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.