Device recall: "PressFT2.6 w/ Two #1 (4 metric) Hi-FiSuturesNP2622009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO…

Class II FDA enforcement event 63115. Recall start date: 26 Jun 2012. Status in the FDA record: Terminated. Termination date: 3 Oct 2014.

Reason for recall, in the words of FDA

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

Class II, in the words of FDA

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

Linvatec Corp. dba ConMed Linvatec started this device recall on 26 Jun 2012. The firm address in the FDA record is in Largo, FL. FDA put the recall in Class II. FDA event 63115 has 6 product records. The first FDA enforcement report date is 24 Oct 2012. The record gives the status Terminated, with the termination date 3 Oct 2014.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL

Recalling firm

Linvatec Corp. dba ConMed Linvatec, Largo, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 63115: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0063-2013	"*PressFT2.6 w/ Two #1 (4 metric) Hi-FiSuturesNP2622009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012
Z-0064-2013	"*PressFT2.6 w/ One #2 (5 metric) Hi-FiSutureNP2612009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012
Z-0065-2013	"*Press FT2.6 w/ One #2 (5 metric) Hi-FiSuture, HIPN22009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012
Z-0066-2013	"*PressFT2.1 w/ Two #0 (3.5 metric) Hi-FiSuturesNP2122009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012
Z-0067-2013	"*PressFT2.1 w/ One #2 (5 metric) Hi-FiSutureNP2112009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012
Z-0068-2013	NP211H*2009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To reattach soft tissue to bone in orthopedic surgical procedures	879 units for all products in recall event	Class II	Terminated	24 Oct 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Linvatec Corp. dba ConMed Linvatec
Initiated	Product (first record)	Type	Class	Records
30 May 2013	*REF C7120*APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic pro	Device	Class II	2
18 Mar 2013	Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endos	Device	Class II	1
6 Mar 2013	GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINV	Device	Class II	1
24 Jan 2013	D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system co	Device	Class III	2
15 Nov 2012	ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch	Device	Class II	1
6 Jul 2012	PopLok Punch labeled in part: "PKL-35M*3.5mmQTY 1PopLok Punch*ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6	Device	Class II	1
10 Apr 2012	"*SENTINELCannulated Drill BitS85808 X 229mm (9")**CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 U	Device	Class II	2
9 Apr 2012	"*All in one CrossFTPunchPFT-00M4.5mm to 6.5mm*CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA	Device	Class II	1
12 Aug 2011	CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate	Device	Class II	1
1 Jul 2011	Catheter Irrigation Set labeled in part: *24K Arthroscopy Outflow/Suction Tubing Set* This Arthroscopy Tubing Set is	Device	Class II	1

Linvatec Corp. dba ConMed Linvatec: all 12 events

Official channels

FDA enforcement report Z-0063-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63115. https://recallregister.com/fda/ii/63115/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
What quantity of product is in FDA event 63115?: The event has 6 product records. The first record gives this quantity: 879 units for all products in recall event
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.