Z-0238-2019Class II

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless...

Name: Z-0238-2019 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless...
Creator: Synthes (USA) Products LLC
Published: 2018-09-12
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2018-09-12 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of... on 2018-09-12. FDA classified it as Class II and gives the reason as "The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length". 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-0238-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Posted: 2018-10-24
Terminated: 2020-04-10
Recalling firm: Synthes (USA) Products LLC
Product: 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The FRIM, DePuy Synthes, sent an URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated 9/12/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory to identify and quarantine the subject product that is still in the original packaging in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section (page 3 of this notification). Please include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. If you have product to be returned: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 " Send a copy of the completed Verification Section (page 3 of this letter) to DePuy Synthes by: " Scan/email: [email protected] " Return any subject product within 30 business days. A credit note will be issued for the returned items. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: " Scan/email: [email protected] NOTE: If the Verification Section is completed on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page number three (3) of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until all product subject to this recall (removal) have been returned. While processing your returns, please maintain a copy of this notice with th
Quantity in commerce: 20
Distribution: US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Product codes and lots: Lot Numbers: L734474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0238-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0238-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-24

Product code HWC

K050636Class IISynthes 3.0Mm Headless Compression ScrewsSynthes (Usa) / cleared 2005-04-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)