CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Best Practice Kit recalled by Medtronic

Medtronic is recalling Best Practice Kit, distributed nationwide in the US. The recall was initiated on 3 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN/A

Quantity recalled478,465 (total for all products)

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-2545-2017
FDA event ID: 77144
Recalling firm: Medtronic, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 3 May 2017
FDA classified: 14 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

3 May 2017	Recall initiated by company
14 Jun 2017	Classified by FDA	+42 days
21 Jun 2017	Published in enforcement report	+7 days

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

Reason for recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

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

Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312

Where it was distributed

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Nationwide California Illinois Pennsylvania Puerto Rico

Questions about this recall

Is Best Practice Kit recalled?

Yes. Medtronic recalled Best Practice Kit on 3 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2545-2017.

Why was it recalled?

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Which lots are affected?

N/A

Where was it sold?

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

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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