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InterSpace Hip Trial
TECRES SPA · Model SPC90Z1 · UDI-DI 08031497002873
HWT
Prescription
10
510(k) clearances
16,914
Adverse events
85
Recalls
430
Facilities
Description
InterSpace Hip Trial is intended to be used for the selection of the right size of InterSpace Hip to be implanted.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.