smith&nephew — Class II medical device recall Z-1105-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-03-28, distributed in CO, IL, NJ, NY, TX. The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used w
| Recall number | Z-1105-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-02-01 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-10-22 |
| Distributed | CO, IL, NJ, NY, TX |
| Countries outside the US | AU, BE, DE, GB, NL, NO |
| Quantity | 28 units |
| Lot numbers | 14AAP6352A |
| Model numbers | 71422159 |
Product
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Reason for recall
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1105-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.