CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

CrossFT Punch, Product Number PFT-45M recalled by Linvatec

Linvatec is recalling CrossFT Punch, Product Number PFT-45M, distributed nationwide in the US. The recall was initiated on 12 Aug 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #156920

Quantity recalled2

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-2147-2012
FDA event ID: 62395
Recalling firm: Linvatec, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2011
FDA classified: 6 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

12 Aug 2011	Recall initiated by company
6 Aug 2012	Classified by FDA	+360 days
15 Aug 2012	Published in enforcement report	+9 days

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

Reason for recall

ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.

Product as listed by the FDA

CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

Where it was distributed

Nationwide Distribution, including the states of Colorado and Pennsylvania.

Nationwide Colorado Pennsylvania

Questions about this recall

Is CrossFT Punch, Product Number PFT-45M recalled?

Yes. Linvatec recalled CrossFT Punch, Product Number PFT-45M on 12 Aug 2011. The recall is Class II and its status is Terminated. Recall number Z-2147-2012.

Why was it recalled?

Which lots are affected?

Lot #156920

Where was it sold?

Nationwide Distribution, including the states of Colorado and Pennsylvania.

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.

More recalls from Linvatec

All 21

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013Device	CLASS II	*REF C7120*Apex Arthroscopy Tubing Set. Intended for use recalled	Linvatec	Other	Nationwide
17 Jul 2013Device	CLASS II	*REF C7122QTY 1**Apex Arthroscopy Tubing Set. Intended for use recalled	Linvatec	Other	Nationwide
10 Jul 2013Device	CLASS II	Genesys Cross FT Suture Anchor with Two #2 recalled by Linvatec	Linvatec	Sterility	6 states
29 May 2013Device	CLASS II	Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures recalled	Linvatec	Device Malfunction	Nationwide
13 Mar 2013Device	CLASS III	D3000 Advantage Drive System, 115v recalled by Linvatec	Linvatec	Other	Nationwide

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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide