🔍 RecallPedia

Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2017 Medtronic Sofamor Danek USA Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d) REF 90-SRK-180410, TU53738-02 e) REF 90-SRK-180412, TU53739-02 f) REF 90-SRK-180414, TU53740-02 g) REF 90-SRK-180510, TU53738-03 h) REF 90-SRK-180512, TU53739-03 i) REF 90-SRK-180514, TU53740-03 j) REF 90-SRK-180610, TU53738-04 k) REF 90-SRK-180612, TU53739-04 l) REF 90-SRK-180614, TU53740-04
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Sofamor Danek USA Inc
Reason for Recall:
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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

Product Codes/Lot Numbers:

Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d) REF 90-SRK-180410, TU53738-02 e) REF 90-SRK-180412, TU53739-02 f) REF 90-SRK-180414, TU53740-02 g) REF 90-SRK-180510, TU53738-03 h) REF 90-SRK-180512, TU53739-03 i) REF 90-SRK-180514, TU53740-03 j) REF 90-SRK-180610, TU53738-04 k) REF 90-SRK-180612, TU53739-04 l) REF 90-SRK-180614, TU53740-04

Distribution:

Distributed in: US, AR, MA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1516-2017

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