Z-0097-2018 Class II Ongoing
FDA device recall Z-0097-2018 was initiated by Smith & Nephew, Inc. on October 24, 2017 and is designated Class II. Reason for recall: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2017
- Initiation Date
- October 24, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Reason for Recall
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Distribution Pattern
US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany
Code Information
Lot number 16LM07111