BEUDAMED
    FDA Recall Terminated

    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

    Recall: Z-0167-2016 · Initiated October 6, 2015

    Recall

    Recall Number
    Z-0167-2016
    Event Number
    72345
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    October 6, 2015
    Posted
    October 30, 2015
    Terminated
    July 15, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

    Reason

    Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

    Action

    Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to: Credit/Returns, Synthes. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 1-866-792-5446 or Scan/email: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. For further questions please call 610-719-6500.

    Distribution

    US Distribution to the state of : TN

    Quantity

    98