Recall Z-0326-2025— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2024-10-15. It names 3 FDA 510(k) clearances: K231448, K211176, K023743. Product: Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.. Reason: The Bipolar assembly contains an oversized Retainer Ring..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-15
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
3 on FDA's record- K231448 — TANDEM Hip System
- K211176 — Smith & Nephew Hip Systems
- K023743 — SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Reason for recall
The Bipolar assembly contains an oversized Retainer Ring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.