Manufacturer

Encore Medical, LP

99 recalls in our database name Encore Medical, LP as the manufacturing or recalling firm.

What the numbers show

Total: 99
Critical: 0
Severe: 5
Most recent: 2026-07-15

Of the 99 recalls from Encore Medical, LP we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–99 of 99

ModerateFDA (Devices)·Z-0042-2018·2017-11-01
Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error
Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.
Product
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conf
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0041-2018·2017-11-01
Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error
Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.
Product
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3102-2017·2017-09-06
Encore Medical Recalls Turon Glenoid Reamers Due to Dimensional Error
Encore Medical is recalling five Turon Glenoid Reamers because the spherical radius cutting surface was manufactured with the wrong dimension, resulting in a larger surface than intended.
Product
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2658-2017·2017-07-12
Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-packaging Error
Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
Product
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2659-2017·2017-07-12
Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-Packaging
Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
Product
3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2017·2017-03-15
Encore Medical Recalls RSP Impaction Fixtures Due to Material Wear
Encore Medical is recalling 626 RSP Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.
Product
RSP Impaction Fixture
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1412-2017·2017-03-15
Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear
Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.
Product
Turon Impaction Fixture
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1191-2017·2017-02-22
Encore Medical Recalls LIMA Modular Revision Hip Stems Due to Sterilization Error
Encore Medical is recalling 13 LIMA Modular Revision Hip Stems because they were inadvertently re-sterilized, which may compromise the integrity of the safety screw.
Product
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1139-2017·2017-02-15
Encore Medical Recalls Empowr PS Knee Tibial Inserts Due to Missing Feature
Encore Medical is recalling 24 Empowr PS Knee Tibial Inserts because they are missing the impaction slot feature.
Product
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2017·2016-12-21
Encore Medical Recalls Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.
Product
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0711-2017·2016-12-14
Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants
Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.
Product
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0325-2017·2016-11-09
FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.
Product
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2606-2016·2016-08-31
Encore Medical Recalls Cobalt HV Bone Cement Due to Packaging Mislabeling
Encore Medical is recalling 866 units of Cobalt HV Bone Cement because the outer packaging incorrectly indicated the product contained Gentamicin, an antibiotic it does not contain.
Product
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2016·2016-07-27
Encore Medical Recalls Modified Linear Standard and Lateral Neck Trials
Encore Medical is recalling 14 neck trial sets because a retaining ring component can disassemble from the body of the neck.
Product
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0626-2016·2016-01-20
Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.
Product
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0179-2016·2015-11-04
Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear
Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.
Product
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to ass
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0180-2016·2015-11-04
Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures
Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.
Product
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then s
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0165-2016·2015-11-04
Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling
Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.
Product
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0131-2016·2015-10-28
Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues
Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.
Product
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previ
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2262-2015·2015-08-05
Encore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error
Encore Medical is recalling 10 units of Foundation Knee System cut blocks because markings are mis-oriented, which could lead to improper surgical cuts.
Product
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1213-2013·2013-05-08
Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Labeling Errors
Encore Medical is recalling five 3DKnee e+ Tibial Inserts because they were shipped with incorrect color-coded labels. The devices were distributed to California and Venezuela.
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0139-2013·2012-10-31
Encore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors
Encore Medical is recalling 6.5mm Cancellous Bone Screws because some units were mislabeled with incorrect sizes, posing a risk of improper surgical fixation.
Product
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2302-2012·2012-09-05
Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Expired Labeling
Encore Medical is recalling 7 units of 3DKnee e+ Tibial Inserts because shelf life labeling was incorrect and the components were expired.
Product
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This inse
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2146-2012·2012-08-15
Encore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws
Encore Medical is recalling 18 bone screws because the package label incorrectly states the size is 30mm, while the actual screw dimension is 25mm.
Product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Category
Medical Device
Distribution
Distributed nationwide