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AcTiFlip and GFS Ultimate Hip
PARCUS MEDICAL LLC · Model 11185SB · UDI-DI 00816342024969
MBI
Prescription
10
510(k) clearances
25,622
Adverse events (5 deaths)
113
Recalls
276
Facilities
Description
AcTiFlip w/ WHIP, Sut Passer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Biomet, Inc. | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop |
| 2025-09-09 | Biomet, Inc. | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. |
| 2025-01-29 | Stryker Corporation | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. |
| 2024-10-29 | Smith & Nephew Inc. | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| 2023-10-25 | Riverpoint Medical, LLC | Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill |
| 2023-08-23 | Stryker Corporation | Expired Product distributed |
| 2023-05-04 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include |
| 2023-05-04 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include |
| 2022-07-13 | Paragon 28, Inc. | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. |
| 2020-11-25 | Biomet, Inc. | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
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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.