Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tra

FDA device recall Z-1428-2012 · posted 2012-04-16 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.

Action taken

Integra issued a Field Safety Notice with an attached Acknowledgement and return Form to all Integra Sales Representatives and Customers via Fed Ex and E-mail on May 19, 2011. The Field Safety Notice informs the customers of the firm's receipt of information concerning several reported incidents that lead to the misalignment of the calcaneal of tibial when used with the Panta Arthrodesis Nail Support Device. The notice goes stated that Integra determined that the misalignment of these screws may be attributed to improper surgical technique and to that end, the Field Safety Notice is being issued in order to reinforce the importance of following the recommended guidelines our lined in the product's Surgical Technique Manual (a copy of the referenced guidelines are provided with the Field Safety Notice (FSN). The FSN goes on to direct the reader/customer to applicable section sections of the manual to which particular attention should be directed in order to minimize the potential for misalignment of the screws. The customers are asked to distribute the information provided to the surgical teams at their various institutions. Moreover, they are also asked to sign and return the enclosed Field Safety Notice Acknowledgement and Return Form so as to document their receipt of the notification and the material provided. Should the customer(s) have questions, they are directed to contact Sean Luland, Director of Marketing-Lower Extremity Reconstruction at Integra LifeScience at: 513-533-7929, for additional information. For questions regarding this recall call 609-275-0500.

Root cause

Use error

Status

Terminated

Product code

HSB

Quantity affected

64 units were distributed

Distribution

Nationwide Distribution including MD, IL, NU, CA, GA, CO, OH, SD, AR, FL, TX, MA, MO, NC, OK, KY, NJ, UT, VA, MN, DC, PA, WA, CT, AZ, IL, MI, AL, NE, TN, NM, NV, LA, OR, DE, WI, ND, NH, MS, SC, IN and

Date initiated

2011-05-19

Date posted

2012-04-16

Date terminated

2013-02-19

Location

Plainsboro, NJ

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