medical Class II Updated 2024-04-10

Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RI

Recalled Product

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

Hazard / Issue

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) Item Number 314-04-32, UDI/DI 10885862199553, Serial Numbers: 2111957, 2161636, 2111956, 2161639, 3755661; b) Item Number 314-04-33, UDI/DI 10885862199560, Serial Numbers: 2112015, 2112016, 2112013, 2112014, 2136760, 2136755, 2424239, 2424237, 2136756, 2424241, 2712715, 3892095, 3892094; c) Item Number 314-04-34, UDI/DI 10885862199577, Serial Numbers: 2111987, 2111986, 2111984, 2138759, 2138757, 2138754, 2138756, 2138755, 2138753, 2425638, 2485901, 2425634, 2138758, 2111985, 2425636, 2425629, 2425627, 2425625; d) Item Number 314-04-35, UDI/DI 10885862199584, Serial Numbers: 2111991, 2430293, 2430292
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.