Z-2624-2017 Class II Terminated
FDA device recall Z-2624-2017 was initiated by Smith & Nephew, Inc. on May 30, 2017 and is designated Class II. Reason for recall: The incorrect Loctite adhesive was used to assemble the impactor heads. The recall status is terminated (terminated December 10, 2021). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 30, 2017
- Termination Date
- December 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Reason for Recall
The incorrect Loctite adhesive was used to assemble the impactor heads.
Distribution Pattern
US distribution to TN
Code Information
Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035