FDAJuly 23, 2019device
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The threads on posts stripping out when tensioned during application process.
What to do
FDA enforcement status: Ongoing
Brands named
new standard device
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
- FDABD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F2025-11-29
- FDAOption"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when ant...2025-09-12
- FDAOffset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.2024-10-30
- FDABioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, ...2024-07-02
- FDAL-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 3845392024-06-14
- FDAGore Tips Set Device, Catalog Number TSET1016, percutaneous liver access2023-06-22
- FDAArgon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 27972023-06-08
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