Food, drugs, devices › Howmedica Osteonics Corp.
Device recall: AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE
FDA enforcement event 99558 is a device recall by Howmedica Osteonics Corp. of Mahwah, NJ, initiated 30 Jul 2026 and classified Class II, with 12 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Howmedica Osteonics Corp. has 48 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ.
Reason for recall
"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and…"
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3195-2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3196-2026 | OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3197-2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS… | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3198-2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3199-2026 | ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT… | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3200-2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED… | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3201-2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS… | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3202-2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3203-2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3204-2026 | TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3205-2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
| Z-3206-2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene) | 12,156 US | Class II | Ongoing | 23 Sep 2026 |
Context
Other enforcement events for Howmedica Osteonics Corp.
All 48 events for Howmedica Osteonics Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.