G7 Acetabular System

510(k) K121874

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

Recall on shared 510(k) K121874; other models may be affected

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK121874	Date23 Nov 2012Cleared	StatusActive

3 recalls · 1 ongoing · FDA

- Ongoing Z-0007-2023 FDA Class II initiated 25 Aug 2022 on shared 510(k) K121874
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
2 recalls, same reason
- Terminated Z-1837-2014 FDA Class II initiated 7 May 2014
- Terminated Z-1838-2014 FDA Class II initiated 7 May 2014
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)