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Medtronic Sofamor Danek USA Inc recalls Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF
Recalled March 29, 2017 · FDA recall Z-1516-2017 · Medtronic Sofamor Danek USA
Hazard
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. · FDA Class II
Units
111 units
Sold at
US distribution to AR, MA
Description
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Product
Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
Manufacturer(s)
Medtronic Sofamor Danek USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →