META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA device recall Z-1806-2025 · posted 2025-05-19 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Action taken
- 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 FieldActions@smith-nephew.com If you have any questions email the firm at the email address above.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 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.
- Date initiated
- 2025-03-18
- Date posted
- 2025-05-19
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew Intramedullary Nail Systems (K210980) | Smith & Nephew, Inc. | 2022-11-14 |
| SURESHOT TAN NAILS AND ACCESSORIES (K092748) | Smith & Nephew, Inc. | 2010-04-26 |