1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 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.
FDA Recall Z-1919-2016 · Posted 2016-06-07
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeJEY
Date Initiated2016-05-02
Date Terminated2016-12-09
Product Quantity19 units
Reason for Recall
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
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
[email protected]. Customers with questions were instructed to call 610-719-5450.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.