Medtronic Sofamor Danek USA Inc recalls Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF

Recalled March 29, 2017 · FDA recall Z-1515-2017 · Medtronic Sofamor Danek USA

Hazard

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. · FDA Class II

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, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 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 →