The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1513-2017·Announced 2017-03-29

Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants 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 is classified as FDA Class II, and the source text describes a structural defect (cracked or broken dovetails) in a medical device without reporting specific injuries or hospitalizations, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling 72 units of the Poly Component Trial, MPCS, which is part of the Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System. 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 packaged in various sizes and configurations, including 3x10L, 3x10R, 3x12L, 3x12R, 3x14L, 3x14R, 4x10L, 4x10R, 4x12L, 4x12R, 4x14L, 4x14R, 5x10L, 5x10R, 5x12L, 5x12R, 5x14L, 5x14R, 6x10L, 6x10R, 6x12L, 6x12R, 6x14L, and 6x14R.

The recall is classified as Class II by the U.S. Food and Drug Administration. The affected units were distributed in the United States to Arkansas (AR) and Massachusetts (MA). Specific lot numbers and reference codes are listed in the agency's recall record, such as REF 90-SRK-192310 (TU53744-01) and REF 90-SRK-191310 (TU53741-01).

Healthcare providers and facilities that have received these products should stop using them and contact Medtronic Sofamor Danek USA Inc for further instructions on how to return or dispose of the affected units.

The recalled product

Product
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…
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
72

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 (20)

  • 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

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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