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Terminated

Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

FDA Recall Z-1383-2013 · Posted 2013-05-24

Recalling FirmOrthopedic Alliance LLC
Recall StatusTerminated
Product CodeKWY
Date Initiated2013-02-20
Date Terminated2014-03-26
Product Quantity37 units

Reason for Recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Firm Action

A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Root Cause

Labeling design

Distribution Pattern

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101670UNITED U2 BIPOLAR IMPLANTUnited Orthopedic Corp. · 2010-10-08

Official Source

View FDA Recall →

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

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