The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1516-2017·Announced 2017-03-29

Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (cracked or broken dovetails) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling 111 units of Poly Component Trial, PS, packaged in various sizes and configurations. The recall is being conducted because the dovetails of the poly trials, Beta 2.0, were observed as either cracked or broken.

The affected products are part 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 specific lot numbers and reference numbers for the recalled units are listed in the agency's recall documentation.

The products were distributed in the United States to Arkansas and Massachusetts. Consumers and healthcare providers should stop using the affected devices and contact Medtronic for further instructions on return or replacement.

The recalled product

Product
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…
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
111

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-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 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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