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Terminated

Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.

FDA Recall Z-0364-2014 · Posted 2013-11-19

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2013-10-10
Date Terminated2014-07-16
Product Quantity25

Reason for Recall

Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.

Firm Action

Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.

Root Cause

Device Design

Distribution Pattern

USA Nationwide Distribution in the states of VA, CA, Ky, and IN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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