META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Recall Z-1806-2025 · Posted 2025-05-19
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Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2025-03-18
Product Quantity75
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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