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 StrykerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Wright Medical Technology with 79 device recalls and 6 510(k) clearances. The most recent is a 510(k) clearance dated Jun 16, 2026: Prophecy Incompass Surgical Planning System.
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.
| Jun 16, 2026 | Prophecy Incompass Surgical Planning SystemK253159 · HSN | 510(k) clearances |
| Oct 29, 2025 | Synchfix EVTK251643 · HTN | 510(k) clearances |
| Sep 30, 2025 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)K252085 · MQV | 510(k) clearances |
| Jun 20, 2025 | Incompass Total Ankle SystemK250037 · HSN | 510(k) clearances |
| Nov 1, 2024 | Prophecy Surgical Planning SystemK241999 · HSN | 510(k) clearances |
| Feb 17, 2023 | PROstep(TM) MIS 5mm Chamfer Screw SystemK221645 · HWC | 510(k) clearances |
| Dec 3, 2021 | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.Class II · The incorrect product is contained in the packaging. | Device recalls |
| Dec 3, 2021 | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.Class II · The incorrect product is contained in the packaging. | Device recalls |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUSClass II · The package contents and package labeling do not match. | Device recalls |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUSClass II · The package contents and package labeling do not match. | Device recalls |
| Aug 26, 2020 | EVOLVE STEM 8.5MM Model # 496S085Class II · Lack of sterility assurance | Device recalls |
| Apr 9, 2020 | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reClass II · One lot of INBONE Tibial Trays is missing the plasma coating. | Device recalls |
| Sep 5, 2012 | Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot NumberClass II · There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | Device recalls |
| Sep 5, 2012 | Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X013Class II · There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | 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