Z-1806-2025Class II

Meta-Tan Lag/compression Screw Kit 90Mm/85mm, Ref: 71642690

Name: Z-1806-2025 Meta-Tan Lag/compression Screw Kit 90Mm/85mm, Ref: 71642690
Creator: Smith & Nephew, Inc.
Published: 2025-03-18
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2025-03-18 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 on 2025-03-18. FDA classified it as Class II and gives the reason as "Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and...". 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-1806-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-18
Posted: 2025-05-19
Recalling firm: Smith & Nephew, Inc.
Product: Meta-Tan Lag/compression Screw Kit 90Mm/85mm, Ref: 71642690
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 3/18/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inspect your inventory and locate any affected devices and quarantine them. 2) If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. 3) Complete and return the notice response section via email to [email protected] If you have any questions email the firm at the email address above.
Quantity in commerce: 75
Distribution: Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
Product codes and lots: UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1806-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-19

Product code HSB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)