Encore Medical, LP

Complete recall history across all FDA and CPSC categories — 97 total recalls

Encore Medical, LP appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (97)

FDA medical device enforcement actions by Encore Medical, LP. Showing most recent 50.

Date Product Reason Class
Jan 15, 2026 Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo... Knee and Humeral socket implants contain incorrect labeling. Class II
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM... Knee and Humeral socket implants contain incorrect labeling. Class II
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK... Knee and Humeral socket implants contain incorrect labeling. Class II
Jan 5, 2026 EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... 942-01-40G acetabular system package was found to contain 942-01-36H acetabul... Class II
Jan 5, 2026 EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 942-01-40G acetabular system package was found to contain 942-01-36H acetabul... Class II
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediat... Class II
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediat... Class II
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... Their is a potential that the reamer may kick or bind up during or immediat... Class II
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediat... Class II
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being... Class II
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being... Class II
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being... Class II
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being... Class II
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a differ... Class II
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a differ... Class II
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a differ... Class II
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a differ... Class II
Dec 18, 2024 EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee T... 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and... Class II
Dec 10, 2024 EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 Knee insert package may contain an acetabular system, which may cause surgica... Class II
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II
Oct 5, 2023 REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Mislabeling Class II
Oct 5, 2023 Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... Mislabeling Class II
Sep 29, 2023 DJO EMPOWR Knee Punch Handle, REF: 801-05-040 Knee punch handle tip is breaking during surgery due to the lack of heat trea... Class II
Sep 25, 2023 RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ... Two different humeral socket Insert devices were swapped during packaging, wh... Class II
Sep 25, 2023 RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ... Two different humeral socket Insert devices were swapped during packaging, wh... Class II
Sep 6, 2023 RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho... Coating hex did not engage with the Straight Mod Hexdriver or with the Hex He... Class II
Aug 22, 2023 EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 Knee insert and acetabular system parts were swapped within inner pack prior ... Class II
Aug 22, 2023 EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H Knee insert and acetabular system parts were swapped within inner pack prior ... Class II
Aug 22, 2023 REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ... Reverse shoulder prosthesis package that should contain 5mmx30 screws could c... Class II
Aug 4, 2023 DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE... Orthopedic device components were not subjected to final sterilization before... Class II
Aug 4, 2023 DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,... Orthopedic device components were not subjected to final sterilization before... Class II
Aug 4, 2023 DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R... Orthopedic device components were not subjected to final sterilization before... Class II
Aug 4, 2023 DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 Orthopedic device components were not subjected to final sterilization before... Class II
Aug 4, 2023 DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 Orthopedic device components were not subjected to final sterilization before... Class II
Feb 28, 2023 EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D... Patella drills are marked with incorrect diameter size of 5.6mm, when they sh... Class II
Dec 22, 2022 EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... Tibial insert implant large boxes were labeled small and the small boxes were... Class II
Aug 12, 2022 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Hip liner implant boxes may contain knee inserts and knee insert boxes may co... Class II
Aug 12, 2022 EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... Hip liner implant boxes may contain knee inserts and knee insert boxes may co... Class II
May 5, 2022 DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 A right, size 8, knee tibial insert package may include a mispackaged, left ,... Class II
Jun 28, 2021 AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part ... Complaints have been received concerning the humeral stem failing to mate wit... Class II
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. ... Packaging mixup; There is a potential that packaging identified as 12mm knee ... Class II
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz.... Packaging mixup; There is a potential that packaging identified as 12mm knee ... Class II
Feb 5, 2021 DJO EMPOWR KNEE Femoral Sizer Incorrect assembly of a subcomponent by a vendor and as a result, the windows... Class II
Sep 9, 2020 EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Si... Due to incomplete machining a small peg remnant on the top of the dome that p... Class II
Aug 31, 2020 AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... Product mislabeled. Use may result in a delay in surgery, stopping of surgery... Class II
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00... Product may be mislabeled with the size etched onto products differing from t... Class II
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Product may be mislabeled with the size etched onto products differing from t... Class II
Aug 3, 2020 DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contai... There is a potential for the retaining pin of the tibial punch handle to beco... Class II

View all 97 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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