—#99553

Product

Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 064320, 189990, 293840, 299010, 299020, 401800, 401810, 406610, 444560, 444600, 517880, 517960, 525360, 534260, 657870, 723150 and 727030.

Why it was recalled

When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.

Timeline

Recall initiated: 2011-04-07
Posted by FDA: 2011-06-30
Terminated: 2013-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.