Howmedica Osteonics Corp.
Complete recall history across all FDA and CPSC categories — 230 total recalls
Howmedica Osteonics Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (230)
FDA medical device enforcement actions by Howmedica Osteonics Corp.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 2, 2026 | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | A potential issue was identified with the torque strength on the external scr... | Class II |
| Nov 12, 2025 | The Stryker CranialMask Tracker is a single-use device consisting of a flexib... | When the device is activated during surgery, the device software issues an er... | Class II |
| Aug 28, 2025 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... | a potential product mix where the package labeled as Catalog Number 0580-1-44... | Class II |
| Sep 4, 2024 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... | Anterior locking tabs on the Triathlon Universal Baseplate are out of specifi... | Class II |
| Aug 7, 2024 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impact... | Class II |
| Aug 5, 2024 | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs ... | A patient specific, custom-made device was supplied for a surgical procedure ... | Class II |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head... | Class II |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head... | Class II |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head... | Class II |
| May 23, 2024 | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 a... | Class II |
| May 23, 2024 | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 621... | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 a... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... | The acetabular shell may have excessive deburring, resulting in a smooth surf... | Class II |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 7 9 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 3 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package ... | Class II |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... | Failed to meet the acceptance criteria for the seal integrity and/or package ... | Class II |
| Dec 1, 2023 | DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replaceme... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Pa... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
| Dec 1, 2023 | DUR PCA MTK REV INS RT Intended for knee replacement Product ... | Product manufactured using UHMWPE raw material over 5 years of age has the po... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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