The Recall Desk
SevereFDA (Devices)·Z-1515-2017·Announced 2017-03-29

Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

Medtronic is recalling Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (cracked or broken dovetails) in a medical device, which meets the rubric criteria for a Severe (Score 4) classification due to the risk of significant injury.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling Poly Component Trial, CR knee implants. The recall involves specific sizes and configurations of the Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System, which is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

The recall was initiated because the dovetails of the poly trials, Beta 2.0, were observed as either cracked or broken. The affected products were distributed in the United States to Arkansas and Massachusetts.

Hospitals and healthcare facilities should stop using the affected Poly Component Trial, CR implants and contact Medtronic for further instructions. Consumers who have had these implants should contact their healthcare provider for guidance.

The recalled product

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, RE
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Orthopedic Implants
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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