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Terminated

Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514 j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610 k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612 l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614 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

FDA Recall Z-1514-2017 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-02-20
Date Terminated2017-10-27
Product Quantity72 units

Reason for Recall

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

Firm Action

Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution to AR, MA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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