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PressFT***2.6 w/ Two #1 (4 metric)… recallZ-0063-2013 · Linvatec Corp. dba ConMed Linvatec · initiated Jun 26, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Linvatec Corp. dba ConMed Linvatec or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0063-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 26, 2012
Posted by the FDA
Oct 15, 2012
Recalling firm
Linvatec Corp. dba ConMed Linvatec
Quantity
879 units for all products in recall event
Product code
MBI
FDA submissions
K112965
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 description

"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

Code information (models, lots, serial numbers)

Item number NP262

Other devices under the same FDA submission

1 device cleared under K112965 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63115).

Sources and updates

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