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MEDPOR

Stryker Leibinger GmbH & Co. KG · Model 9951 · UDI-DI 07613252086512

FWP Prescription

510(k) clearances

240

Adverse events (1 deaths)

Recalls

Facilities

Description

Design M Malar Sizer Set (Sil Non-Ster)

Recalls

Date	Firm	Reason
2025-09-26	DSAART LLC	Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
2014-12-17	Stryker Craniomaxillofacial Division	Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively
2014-12-17	Stryker Craniomaxillofacial Division	Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively
2014-12-17	Stryker Craniomaxillofacial Division	Potential for implant damage, implant cracking off/breaking intra-operatively.
2013-08-30	Implantech Associates Inc	Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do

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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.