Biomet Surgical Implant Reamer Recall: Packaging Sterile Barrier Risk

Plain-English summary

Biomet, Inc. is recalling JUGGERLOC SLOTTED REAMER surgical implants in sizes 5MM through 8MM distributed worldwide to 28 U.S. states, Australia, Japan, and the Netherlands. The recall affects 702 units across 29 affected lots.

The vacuum-sealed packaging may not have sufficient adhesion on all sides, potentially compromising the device's sterile barrier. A compromised sterile barrier increases the risk of post-surgical infection at the implant site.

Infection resulting from a compromised barrier may require additional surgical intervention or extension of the original surgery. Patients who received one of these devices should contact their healthcare provider to determine if their specific device is affected.

Healthcare facilities should immediately identify affected lot numbers in their inventory and discontinue use of the recalled devices. This is a Class II recall from the FDA.

The recalled product

Product

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.

Manufacturer

Biomet, Inc.

Category

Medical Device — Surgical Implant

Hazard

• sterile-barrier-compromise
• infection-risk

Affected units

702

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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