Z-1513-2017 Class II Terminated
FDA device recall Z-1513-2017 was initiated by Medtronic Sofamor Danek USA Inc on February 20, 2017 and is designated Class II. Reason for recall: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. The recall status is terminated (terminated October 27, 2017). Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- October 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
Product Description
Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 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.
Reason for Recall
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Distribution Pattern
US distribution to AR, MA
Code Information
Lot Numbers: a) REF 90-SRK-192310, TU53744-01 b) REF 90-SRK-191310, TU53741-01 c) REF 90-SRK-192312, TU53745-01 d) REF 90-SRK-191312, TU53742-01 e) REF 90-SRK-192314, TU53746-01 f) REF 90-SRK-191314, TU53743-01 g) REF 90-SRK-192410, TU53744-02 h) REF 90-SRK-191410, TU53741-02 i) REF 90-SRK-192412, TU53745-02 j) REF 90-SRK-191412, TU53742-02 k) REF 90-SRK-192414, TU53746-02 l) REF 90-SRK-191414, TU53743-02 m) REF 90-SRK-192510, TU53744-03 n) REF 90-SRK-191510, TU53741-03 o) REF 90-SRK-192512, TU53745-03 p) REF 90-SRK-191512, TU53742-03 q) REF 90-SRK-192514, TU53746-03 r) REF 90-SRK-191514, TU53743-03 s) REF 90-SRK-192610, TU53744-04 t) REF 90-SRK-191610, TU53741-04 u) REF 90-SRK-192612, TU53745-04 v) REF 90-SRK-191612, TU53742-04 w) REF 90-SRK-192614, TU53746-04 x) REF 90-SRK-191614, TU53743-04