Z-2171-2021Class II

Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Name: Z-2171-2021 Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Creator: Stryker GmbH
Published: 2021-05-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2021-05-27 / Open, Classified / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S on 2021-05-27. FDA classified it as Class II and gives the reason as "The devices have a different inner diameter than the diameter specified on the outer box label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2171-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-27
Posted: 2021-07-30
Recalling firm: Stryker Corp.
Product: Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The devices have a different inner diameter than the diameter specified on the outer box label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE RECALL notice dated 5/27/21 was sent to customers. Actions to be Taken by the Customer/User: Our records indicate that you may have received one or more of the affected products. It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing [email protected]. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-879-4609 or email to [email protected]. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8. Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2644769 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall Business
Quantity in commerce: 242
Distribution: US Nationwide Distribution
Product codes and lots: GTIN 04546540715357, Lot Number K03CC4F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2171-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2170-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-07-30
Z-2171-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-07-30

Product code HSB

K131365Class IIT2 Tibial Nailing SystemStryker Trauma AG / cleared 2013-10-10

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