—#93837

Product

10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 019900, 019950 and 821060.

Why it was recalled

The affected instruments are discolored and/or have a sticky residue on the end.

Root cause (FDA determination)

Packaging change control

Action the firm took

The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.

Timeline

Recall initiated: 2010-07-01
Posted by FDA: 2010-09-28
Terminated: 2012-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.