ACTIVE recall · LOT-TI-0482 · Smith&Nephew Genesis II femoral component. Class II · FDA notice received 2026-05-18 14:18. 14 implants traced from this lot · 11 implanted in patients · 3 in inventory (quarantined). Patient notification deadline: 2026-05-25.
Recall lot
LOT-TI-0482
S&N Genesis II
14 implants
FDA Class II
Implants (14)
IMPL-TKR-K7821
implanted · Apollo Indore
IMPL-TKR-K7822
implanted · Apollo Indore
IMPL-TKR-K7825
implanted · Apollo Chennai
IMPL-TKR-K7826
in quarantine · Apollo Indore
+ 10 more
Patient cases (11)
CASE-0442-01
PT-AP-0442 · TKR Right · Dr Bhatt
CASE-0463-01
PT-AP-0463 · TKR Right · Dr Bhatt
CASE-CHE-0102
PT-CHE-0102 · TKR Left · Dr Kumar
+ 8 more cases
Patients (11)
PT-AP-0442
M. Iyer · 62 · M · in follow-up
PT-AP-0463
S. Kumar · 58 · F · in follow-up
PT-CHE-0102
R. Pillai · 71 · M · not yet notified
+ 8 more patients
Status of patient notifications
Notified & acknowledged
7
Notified pending ack
2
Not yet notified
2
Inventory status
In quarantine3 units
In OT pre-stage0 units · blocked at scan
Disposed0
Vendor return RMARMA-S&N-2026-0148
Regulatory
FDA notice received2026-05-18 14:18
CDSCO notificationsubmitted
Hospital reporting (NABH)filed
Group-level auditcomplete
Recommended next actions
Notify the 2 remaining un-notified patients within 48h
Schedule explant evaluation review by Dr. Bhatt + Dr. Kumar
Vendor RMA — physical return of 3 quarantined units
Final compliance report to CDSCO & NABH