FDAFDA · Food and drugs·Recall number Z-1514-2017
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
Published March 29, 2017 · Recall initiated: February 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- US distribution to AR, MA
- Lot
- Lot Numbers: a) REF 90-SRK-170310, TU53733-01 b) REF 90-SRK-170312, TU53736-01 c) REF 90-SRK-170314, TU53737-01 d) REF 90-SRK-170410, TU53733-02 e) REF 90-SRK-170412, TU53736-02 f) REF 90-SRK-170414, TU53737-02 g) REF 90-SRK-170510, TU53733-03 h) REF 90-SRK-170512, TU53736-03 i) REF 90-SRK-170514, TU53737-03 j) REF 90-SRK-170610, TU53733-04 k) REF 90-SRK-170612, TU53736-04 l) REF 90-SRK-170614, TU53737-04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.