Recall Z-1920-2016 ยท JEY Plate, Bone
Synthes (USA) Products LLC
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
| Date | Jun 7, 2016 (initiated May 2, 2016) |
| Status | Terminated |
| Reason | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes sent an Urgent Medical Device Recall Notice dated May 2, 2016, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory immediately and remove the affected lots from their stock. Customers were instructed to call 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product., customers were also asked to complete the Verification Section and scan/email to Synthes4096@stericycle.com. Customers with questions were instructed to call 610-719 |
| Quantity | 14 units |
| Distribution | Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS. |
| FDA record | Open on fda.gov |