Z-0066-2013Class II

"PressFT2.1 w/ Two #0 (3.5 metric) Hi-FiSuturesNP2122009-02CONMED LINVATEC 11311 CONCEPT...

Name: Z-0066-2013 "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2012-06-26
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2012-06-26 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft... on 2012-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0066-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-26
Posted: 2012-10-15
Terminated: 2014-10-03
Recalling firm: Linvatec Corporation
Product: "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConMed Linvatec sent an Urgent Medical Device Recall Notification letter on June 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility for the recalled products, segregate them for return to ConMed Linvatec. The customers were also told to return the REPLY FORM to the Regulatory Department at the firm. For questions customers were instructed to call 800-237-0169 or email at [email protected]. For questions regarding this recall call 727-392-6464.
Quantity in commerce: 879 units for all products in recall event
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
Product codes and lots: Item number NP212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0066-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0063-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0064-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0065-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0066-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0067-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15
Z-0068-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-15

Product code MBI

K112965Class IINano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec / cleared 2011-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)