Interspace Tapered Wedge Stem
TECRES SPA · Model SPC0423 · UDI-DI 08031497001623
Description
Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-21 | Howmedica Osteonics Corp. | Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010) |
| 2015-02-11 | DePuy Orthopaedics, Inc. | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed. |
| 2013-11-04 | Zimmer, Inc. | The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label. |
| 2013-09-16 | DePuy Orthopaedics, Inc. | The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated |
| 2006-11-07 | Stryker Howmedica Osteonics Corp. | The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect |
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