Z-2884-2018Class II

Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT...

Name: Z-2884-2018 Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT...
Creator: Stryker GmbH
Published: 2018-06-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-06-27 / Terminated / root cause: packaging

FDA source

Stryker GmbH began a recall of Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL... on 2018-06-27. FDA classified it as Class II and gives the reason as "Incomplete seal on the Tyvek lid may compromise the sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2884-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Posted: 2018-08-22
Terminated: 2020-04-13
Recalling firm: Stryker Corp.
Product: Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Incomplete seal on the Tyvek lid may compromise the sterility of the device
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stryker notified consignee via UPS (with return receipt) on June 27, 2018 advising user of the problem, quarantine product and return. Complete and sign the Recall Notification Business Reply Form. Contact (201) 831-6693.
Quantity in commerce: 38
Distribution: US distribution to KY
Product codes and lots: Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2884-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2884-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-22

Product code HSB

K051590Class IIT2 Ankle Arthrodesis NailHowmedica Osteonics Corp. / cleared 2005-07-29

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)