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CeMend Shoulder Spacer

G21 SRL · Model AR-902-1048 · UDI-DI 08058964729231

MBB KWS Prescription

510(k) clearances

3,697

Adverse events (48 deaths)

Recalls

Facilities

Description

The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.

Recalls

Date	Firm	Reason
2022-10-21	Howmedica Osteonics Corp.	Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
2015-02-11	DePuy Orthopaedics, Inc.	One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
2013-11-04	Zimmer, Inc.	The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
2013-09-16	DePuy Orthopaedics, Inc.	The SmartSet GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated
2006-11-07	Stryker Howmedica Osteonics Corp.	The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect

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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.