Agency classClass IIOur severity:High FDA (Devices)·Z-1514-2017·Announced 2017-03-29

Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

Medtronic is recalling 72 Poly Component Trial knee implants because their 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 hazard involves a structural defect (cracked or broken dovetails) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling 72 units of the Poly Component Trial, UCCS, which is part of the Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System. The recall covers various sizes and configurations, including REF 90-SRK-170310 through 90-SRK-170614, with specific lot numbers ranging from TU53733-01 to TU53737-04.

The recall was initiated because the dovetails of the poly trials, Beta 2.0, were observed as either cracked or broken. The RO Total Knee Arthroplasty System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

The affected units were distributed in the United States to Arkansas and Massachusetts. Consumers and healthcare providers should stop using the affected devices and contact Medtronic Sofamor Danek USA Inc for further instructions.

The recalled product

Product: Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF…
Manufacturer: Medtronic Sofamor Danek USA Inc
Category: Medical Device — Orthopedic Implants
Hazard: structural-defect
cracked-component
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 (13)

Lot Numbers: a) REF 90-SRK-170310
TU53733-01 b) REF 90-SRK-170312
TU53736-01 c) REF 90-SRK-170314
TU53737-01 d) REF 90-SRK-170410
TU53733-02 e) REF 90-SRK-170412
TU53736-02 f) REF 90-SRK-170414
TU53737-02 g) REF 90-SRK-170510
TU53733-03 h) REF 90-SRK-170512
TU53736-03 i) REF 90-SRK-170514
TU53737-03 j) REF 90-SRK-170610
TU53733-04 k) REF 90-SRK-170612
TU53736-04 l) REF 90-SRK-170614
TU53737-04

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 →

Same manufacturer · Medtronic Sofamor Danek USA Inc

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