Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Medtronic Sofamor Danek USA Inc
Category: Medical Device — Orthopedic Implants
Hazard: structural-defect
fracture

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 →

Same manufacturer · Medtronic Sofamor Danek USA Inc

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