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Offset Cup Impactor 7/16-20 UNF Long = 3mm

MPS Micro Precision Systems AG · Model T18303 · UDI-DI 07640187917161

HWA Prescription

510(k) clearances

19,425

Adverse events

Recalls

303

Facilities

Description

Offset cup impactors are to be used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. The cup impactor is equipped with a suitable connection system to the acetabular cup (e.g. a thread). A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument. This is an reusable device.

Recalls

Date	Firm	Reason
2026-02-03	Exactech, Inc.	Impactor handle may be missing cross-pin
2026-02-03	Exactech, Inc.	Impactor handle may be missing cross-pin
2024-10-30	INCIPIO DEVICES	Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
2023-06-05	Exactech, Inc.	The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
2020-05-12	XTANT Medical	The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
2019-08-16	Enztec Limited	The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor
2019-07-24	Exactech, Inc.	The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
2017-08-28	Zimmer Biomet, Inc.	Potential for the Persona Partial Knee Impactor Pad to fracture.
2017-02-09	Encore Medical, Lp	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titaniu
2017-02-09	Encore Medical, Lp	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titaniu

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.