—#146070

Product

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 product code: JEY — Plate, Bone
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K030069, K062789
Affected lot / code info: Catalog # 851.690.01S, Lot # 6904416, 6904418, 7672126

Why it was recalled

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 610-719-5450.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

Timeline

Recall initiated: 2016-05-02
Posted by FDA: 2016-06-07
Terminated: 2016-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146070. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.