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Soft Tissue Sleeve

CURVAFIX, INC. · Model CTS-001 · UDI-DI 10855068008447

FZX Prescription

510(k) clearances

8,516

Adverse events (4 deaths)

Recalls

524

Facilities

Description

A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other orthopaedic instrumentation into the surgical site.

Recalls

Date	Firm	Reason
2023-11-30	Waldemar Link GmbH & Co. KG (Mfg Site)	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resec
2022-10-10	Hologic, Inc	IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2018-03-26	Zimmer Biomet, Inc.	Potential failure of sterile packaging seal.
2017-08-07	Synthes, Inc.	May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is dr
2017-04-25	Cook Inc.	reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2016-08-09	Zimmer Biomet, Inc.	Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ
2016-06-07	Synthes (USA) Products LLC	DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified

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Data 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.