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Smith & Nephew, Inc. · Model 014407 · UDI-DI 03596010095329

KQZ Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

115

Facilities

Description

GUHL ANKLE DISTRACTOR FOOT STRAPS, STERILE, LATEX FREE BOX OF 6

Recalls

Date	Firm	Reason
2021-12-14	Smith & Nephew, Inc.	Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14	Ossur H / F	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

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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.