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.
November 4, 2015Medical DevicesFDA
Encore Medical, Lp recalls Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the
Hazard: During the 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.
November 4, 2015Medical DevicesFDA
Encore Medical, Lp recalls Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on
Hazard: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
November 4, 2015Medical DevicesFDA
Encore Medical, Lp recalls Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee
Hazard: The labeling is missing the size/diameter information.
October 28, 2015Medical DevicesFDA
Encore Medical, Lp recalls AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless applicat
Hazard: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
August 5, 2015Medical DevicesFDA
Encore Medical, Lp recalls FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Hazard: The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
May 8, 2013Medical DevicesFDA
Encore Medical, Lp recalls 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Hazard: U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
October 31, 2012Medical DevicesFDA
Encore Medical, Lp recalls 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Hazard: A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
September 5, 2012Medical DevicesFDA
Encore Medical, Lp recalls 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is inte
Hazard: The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
August 15, 2012Medical DevicesFDA
Encore Medical, Lp recalls djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or frac
Hazard: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.