Biomet, Inc.: BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG

Is my product affected?

BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriat

• UPC 00887868446191
• UPC 00887868446207
• UPC 00887868446313

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling DVR Crosslock Extra Long Plates (left and right) and DVR Crosslock Extra Extra Long Plates due to a packaging defect. The packaging of these implants may not have sufficient adhesion on all sides, which could compromise the sterile barrier and allow contamination. If used, these products pose a risk of infection that could require additional surgical intervention or extension of surgery to locate a replacement part. The recalled products were distributed worldwide, including to 28 U.S. states, Australia, Japan, and the Netherlands, affecting a total of 38 units across six specific lots.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

Details from the source

Reason for recall: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. Distribution: Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands Quantity: 38 Lot/code info: 6 lots: Lot #, UDI - [101220, (01)00887868446191(17)310623(10)101220], [101340, (01)00887868446207(17)310625(10)101340], [101450, (01)00887868446313(17)310630(10)101450], [101560, (01)00887868446191(17)310624(10)101560], [119180, (01)00887868446313(17)310630(10)119180], [154060, (01)00887868446313(17)310630(10)154060]

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels o2022-02-14
• BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.2022-02-14
• BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 8290321702022-02-14
• Compella Bariatric Bed System2022-02-14
• Compella Therapy Air Supply Unit2022-02-14

All FDA (Device enforcement) recalls