BEUDAMED
    FDA Recall Terminated

    Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Recall: Z-1130-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-1130-2016
    Event Number
    72900
    FEI Number
    1000132037
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 11, 2016
    Posted
    March 12, 2016
    Terminated
    April 13, 2017
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    Description

    Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    Reason

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

    Distribution

    US Nationwide Distribution

    Quantity

    4018