Z-2155-2016Class II

4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone

Name: Z-2155-2016 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone
Creator: Synthes (USA) Products LLC
Published: 2016-02-16
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-02-16 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large... on 2016-02-16. FDA classified it as Class II and gives the reason as "Labeling does not match the cleared indications for use in the United States and Canada". 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-2155-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-07-11
Terminated: 2017-06-01
Recalling firm: Synthes (USA) Products LLC
Product: 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Labeling does not match the cleared indications for use in the United States and Canada.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.
Quantity in commerce: 19,497,844 units in total
Distribution: US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product codes and lots: Many affected part numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2153-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2154-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2155-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2156-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2157-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11
Z-2158-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11

Product code HWC

K021932Class IISynthes 6.5 Mm Cannulated ScrewSynthes (Usa) / cleared 2002-09-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)