Z-1918-2016Class II

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5...

Name: Z-1918-2016 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5...
Creator: Synthes (USA) Products LLC
Published: 2016-05-02
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-02 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with... on 2016-05-02. FDA classified it as Class II and gives the reason as "Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1918-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2016-06-07
Terminated: 2016-12-09
Recalling firm: Synthes (USA) Products LLC
Product: 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 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.
Product code: JEY Plate, Bone
Reason for recall: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Root cause tag: labeling and UDI
FDA 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 [email protected]. Customers with questions were instructed to call 610-719-5450.
Quantity in commerce: 22 units
Distribution: Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Product codes and lots: Catalog # 851.689.01S, Lot # 7672066 and 7672089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1918-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1918-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07
Z-1919-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07
Z-1920-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code JEY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)