CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Poly Component Trial, CR recalled by Medtronic Sofamor Danek USA

Medtronic Sofamor Danek USA is recalling Poly Component Trial, CR, distributed in Arkansas, Massachusetts. The recall was initiated on 20 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1515-2017
FDA event ID: 76694
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2017
FDA classified: 21 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Hip & Knee Implants

Timeline

20 Feb 2017	Recall initiated by company
21 Mar 2017	Classified by FDA	+29 days
29 Mar 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

Where it was distributed

US distribution to AR, MA

Arkansas Massachusetts

Questions about this recall

Is Poly Component Trial, CR recalled?

Yes. Medtronic Sofamor Danek USA recalled Poly Component Trial, CR on 20 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1515-2017.

Why was it recalled?

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

Which lots are affected?

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

Where was it sold?

US distribution to AR, MA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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