Poly Component Trial recall
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
Why was Poly Component Trial recalled?
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04
- 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
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Distribution
- US distribution to AR, MA
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)