Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DJO GlobalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Encore Medical with 99 device recalls and 89 510(k) clearances. The most recent is a 510(k) clearance dated Oct 2, 2026: AltiVate Reverse® Glenosphere with RAVN™ Technology.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 2, 2026 | AltiVate Reverse® Glenosphere with RAVN™ TechnologyK263086 · PHX | 510(k) clearances |
| Jan 15, 2026 | AltiVate Reverse® ADLC GlenosphereK252567 · PHX | 510(k) clearances |
| Dec 19, 2025 | EMPOWR KneeK252974 · JWH | 510(k) clearances |
| Nov 12, 2025 | EMPOWR Acetabular® Liner ExtensionK251833 · LPH | 510(k) clearances |
| Aug 5, 2025 | AltiVate Reverse® GlenoidK252141 · PHX | 510(k) clearances |
| Jul 8, 2025 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251776 · JWH | 510(k) clearances |
| Jul 2, 2025 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)K251241 · JWH | 510(k) clearances |
| May 16, 2025 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid SystemK251184 · PHX | 510(k) clearances |
| Feb 4, 2019 | EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096Class II · The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additiona | Device recalls |
| Sep 21, 2018 | Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 49Class II · Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body | Device recalls |
| Sep 19, 2018 | Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.Class II · Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit sha | Device recalls |
| Jun 26, 2018 | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize aClass II · A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompa | Device recalls |
| May 14, 2018 | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee systeClass II · After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. | Device recalls |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder SysClass II · It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial ( | Device recalls |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic ShoulderClass II · It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial ( | Device recalls |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder SysClass II · It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial ( | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
