Home / Brands / Encore Medical
Encore Medical Recalls
99 recalls on record · August 15, 2012 to July 15, 2026 · Medical Devices
Recalls by year
12
13
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 8, 2018Medical DevicesFDA
Encore Medical, Lp recalls Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with li
Hazard: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVa
Hazard: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate A
Hazard: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate A
Hazard: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate A
Hazard: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate A
Hazard: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
April 4, 2018Medical DevicesFDA
Encore Medical, Lp recalls AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Ort
Hazard: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
January 17, 2018Medical DevicesFDA
Encore Medical, Lp recalls EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Hazard: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
January 17, 2018Medical DevicesFDA
Encore Medical, Lp recalls EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
Hazard: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
January 17, 2018Medical DevicesFDA
Encore Medical, Lp recalls EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Hazard: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
January 17, 2018Medical DevicesFDA
Encore Medical, Lp recalls DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Hazard: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
November 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobal
Hazard: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
November 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobal
Hazard: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
November 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement
Hazard: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
November 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement
Hazard: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
November 1, 2017Medical DevicesFDA
Encore Medical, Lp recalls EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are
Hazard: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
November 1, 2017Medical DevicesFDA
Encore Medical, Lp recalls EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts
Hazard: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
September 6, 2017Medical DevicesFDA
Encore Medical, Lp recalls MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 R
Hazard: It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
July 12, 2017Medical DevicesFDA
Encore Medical, Lp recalls 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts a
Hazard: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
July 12, 2017Medical DevicesFDA
Encore Medical, Lp recalls 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts
Hazard: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
March 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls RSP Impaction Fixture
Hazard: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
March 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Turon Impaction Fixture
Hazard: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
February 22, 2017Medical DevicesFDA
Encore Medical, Lp recalls LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up
Hazard: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
February 15, 2017Medical DevicesFDA
Encore Medical, Lp recalls Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E
Hazard: The Empowr PS Insert was reported as missing the impaction slot feature.
December 21, 2016Medical DevicesFDA
Encore Medical, Lp recalls Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of
Hazard: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
December 14, 2016Medical DevicesFDA
Encore Medical, Lp recalls Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior crucia
Hazard: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
November 9, 2016Medical DevicesFDA
Encore Medical, Lp recalls Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implan
Hazard: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
August 31, 2016Medical DevicesFDA
Encore Medical, Lp recalls Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized compon
Hazard: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
July 27, 2016Medical DevicesFDA
Encore Medical, Lp recalls MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Hazard: Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
January 20, 2016Medical DevicesFDA
Encore Medical, Lp recalls AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catal
Hazard: The trial shell mating feature on the broach is undersized.