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Gun-shaped Bone Cement Filler Devices

Shanghai Lange Medtech Co., Ltd. · Model S14-02 · UDI-DI 06937321301384

OAR

510(k) clearances

191

Adverse events (1 deaths)

Recalls

Facilities

Description

The product is intended to be used by medical institutions for mixing bone cement and delivering bone cement (polymethyl methacrylate, PMMA) to the target position in the medullary cavity during minimally invasive orthopedic surgeries.

Recalls

Date	Firm	Reason
2024-08-19	Merit Medical Systems, Inc.	Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
2024-06-03	Stryker Corporation	Expired Products distributed to customers
2020-02-13	Merit Medical Systems, Inc.	Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five
2020-02-13	Merit Medical Systems, Inc.	Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five
2017-12-06	Medtronic Sofamor Danek USA Inc	Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-05-17	Medtronic Sofamor Danek USA Inc	The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may
2013-07-30	Synthes USA HQ, Inc.	Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.
2012-11-10	Orthovita, Inc., dBA Stryker Orthobiologics.	There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bend

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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.