—#107519

Product

Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062494
Affected lot / code info: Item 37728, Lot 989520; Lot 850910 ; Lot 091250 Lot 429270

Why it was recalled

Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574-372-1638. Questions should be directed to 574-372-3983 or 574-371-3009 M- F, 8 AM- 5 PM, (ET).

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.

Timeline

Recall initiated: 2012-03-15
Posted by FDA: 2012-04-19
Terminated: 2013-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.