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 |
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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