Z-2792-2016Class II

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems...

Name: Z-2792-2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-06-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-06-30 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a... on 2016-06-30. FDA classified it as Class II and gives the reason as "Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field". 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-2792-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-09-13
Terminated: 2017-06-21
Recalling firm: Howmedica Osteonics Corp
Product: Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 30, 2016 by e-mail to its customer requesting that they quarantine affected devices and sent the letter via UPS (with return receipt) on July 1, 2016. The letter described the product, problem and actions to be taken. The customer was instructed to inform users of the Medical Device Removal and forward the notice to all who need to be aware; inspect your inventory and return affected products to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team; 325 Corporate Drive; Dock M-East , Mahwah, NJ 07431 REF: PFA #2016-094; complete and return the Business Reply Form via email to [email protected] within 5 days; and keep a copy of the completed and executed Business Reply Form for your records. If you have any questions, feel free to contact the Mgr., Divisional Regulatory Compliance, Marketing Quality at (201) 831-6693.
Quantity in commerce: 1 unit in total
Distribution: US distribution to state of: CA.
Product codes and lots: Catalog number 18251032S and Lot Code K288335

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2792-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2791-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-13
Z-2792-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-13

Product code HSB

K010801Class IIT2 Femoral NailHowmedica Osteonics Corp. / cleared 2001-04-06

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