1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Res

FDA device recall Z-1919-2016 · posted 2016-06-07 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JEY

Quantity affected

19 units

Distribution

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

Date initiated

2016-05-02

Date posted

2016-06-07

Date terminated

2016-12-09

Location

West Chester, PA

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