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1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm… recallZ-1918-2016 · Synthes (USA) Products LLC · initiated May 2, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1918-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 2, 2016
Posted by the FDA
Jun 7, 2016
Recalling firm
Synthes (USA) Products LLC
Quantity
22 units
Product code
JEY
FDA submissions
K030069, K062789
Distribution
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

Product description

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.

Code information (models, lots, serial numbers)

Catalog # 851.689.01S, Lot # 7672066 and 7672089

Other devices under the same FDA submission

25 devices cleared under K030069, K062789 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 74053).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page