Recall Z-1799-2015 ยท FZX Guide, Surgical, Instrument
Synthes, Inc.
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,
| Date | Jun 15, 2015 (initiated May 28, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | DePuy Synthes sent an Urgent Notice Urgent notice dated May 28, 2015, to all affected customers to advise them of the defect and patient risks associated with its use. Customers were instructed if they have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 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 |
| Quantity | 3747 US, 19 Foreign |
| Distribution | Worldwide Distribution-US (nationwide) and internationlly to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.