SpaceFlex Acetabular Cup
G21 SRL · Model 900203 · UDI-DI 08058964727923
Description
The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Total Joint Orthopedics, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2024-10-15 | Smith & Nephew, Inc. | The Bipolar assembly contains an oversized Retainer Ring. |
| 2024-04-26 | Exactech, Inc. | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packagin |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
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