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R3 ACETABULAR

Smith & Nephew, Inc. · Model 71331864 · UDI-DI 03596010597656

MRA MBL Prescription

510(k) clearances

5,340

Adverse events (10 deaths)

Recalls

Facilities

Description

R3 0 HOLE ACETABULAR SHELL 64MM

Recalls

Date	Firm	Reason
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2016-04-12	Exactech, Inc.	Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
2013-10-11	Zimmer, Inc.	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determ
2012-09-14	Zimmer, Inc.	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012
2012-09-14	Zimmer, Inc.	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012
2011-03-11	Smith & Nephew Inc	During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufactur

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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.