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G7 OSSEOTI ACETABULAR SHELL

Biomet Orthopedics, LLC · Model 110010239 · UDI-DI 00880304544147

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510(k) clearances

5,676

Adverse events (21 deaths)

Recalls

156

Facilities

Recalls

Date	Firm	Reason
2023-11-21	Exactech, Inc.	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2022-08-11	Exactech, Inc.	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2022-08-11	Exactech, Inc.	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2018-09-21	Encore Medical, Lp	Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, d
2015-05-06	Smith & Nephew, Inc.	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06	Smith & Nephew, Inc.	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06	Smith & Nephew, Inc.	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06	Smith & Nephew, Inc.	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06	Smith & Nephew, Inc.	The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2012-08-27	Zimmer, Inc.	Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, mat

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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.