Osteotec SFI Sizer
OSTEOTEC LIMITED · Model OSTF-Sizer · UDI-DI 05060183095809
Description
The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. These eleven sizes effectively constitute components of the Osteotec SFI Sizer, which is placed on the market as a single medical device. Each individual sizer is comprised of a blue flexible silicone elastomer. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-27 | LINK BIO CORP | The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inse |
| 2022-07-13 | Materialise USA LLC | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK |
| 2022-06-29 | DePuy Orthopaedics, Inc. | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & |
| 2017-12-20 | Integra LifeSciences Corp. | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling p |
| 2017-08-10 | Aesculap Implant Systems LLC | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect impl |
| 2017-04-11 | Biomet Microfixation, LLC | Part of the number on the tray lid differ from the part number on the base. |
| 2015-06-24 | Encore Medical, Lp | The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the res |
| 2015-06-03 | Biomet, Inc. | Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link. |
| 2014-09-24 | Biomet, Inc. | An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial. |
| 2014-03-28 | DePuy Orthopaedics, Inc. | Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulde |
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