Z-2393-2018Class II

Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S

Name: Z-2393-2018 Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S
Creator: Stryker GmbH
Published: 2018-04-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-04-27 / Terminated / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S on 2018-04-27. FDA classified it as Class II and gives the reason as "The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail...". 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-2393-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-27
Posted: 2018-07-10
Terminated: 2020-05-21
Recalling firm: Stryker Corp.
Product: Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: [email protected]
Quantity in commerce: 12
Distribution: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Product codes and lots: GTIN 04546540197771; Lot code: K074846

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2393-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2393-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2394-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2395-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2396-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2397-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2398-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2399-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2400-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2401-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2402-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2403-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2404-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2405-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2406-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2407-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2408-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10

Product code HSB

K003018Class IITitan Tibial NailHowmedica Osteonics Corp. / cleared 2000-12-15

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)