Z-1800-2015Class II

3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated...

Name: Z-1800-2015 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated...
Creator: Synthes, Inc.
Published: 2015-05-13
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-05-13 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and... on 2015-05-13. FDA classified it as Class II and gives the reason as "Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1800-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-06-15
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers to advise them about the issue and associated risks. These accounts were asked to review inventory, immediately remove the affected lots that are still in the original packaging from stock, and to complete and return the response and return authorization forms. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes consultant.
Quantity in commerce: 54
Distribution: Nationwide Distribution
Product codes and lots: Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1800-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1800-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)