FDAFDA · Food and drugs·Recall number Z-1799-2015
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
Published June 24, 2015 · Recall initiated: May 28, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Worldwide Distribution-US (nationwide) and internationlly to Canada
- Lot
- Part Number: 03.120.023, with lot numbers: 1825699 1825946 1959344 1959346 3052800 3066995 3066996 3066997 3092693 3092737 3139434 3139480 3139483 3139485 3159152 3167363 3172147 3207364 3218030 3218068 3223545 3224270 3224271 3224275 3224581 3224582 3224583 3233445 3288206 3422091 3447606 3469240 3502469 3535235 3556421 3556422 3584316 3642892 3740917 3740919 3740920 3740924 3775480 3775482 3811200 7510644 7510645 7510647 7510648 7542178 7555756 7629268 7699116 7699117 7742370 7742371 7742372 7778806 7778807 7821741 7878176 7995396 8016667 8028575 8068778 8070887 8070891 8195690 8210669 8217914 8408715
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.