—#69084

Product

Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060694
Affected lot / code info: Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250.

Why it was recalled

The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were notified by Urgent Medical Device Removal Notice dated 3/13/08 to discontinue use of the instruments and return to the firm. Operating room managers were sent a separate letter dated 3/13/08 and informed of the possible effects to patients from previous use of this instrument and it was suggested they monitor patients for these effects. If you have any questions contact Mary Hardesty at 1-800-348-9500 or (574) 372-3983.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution.

Timeline

Recall initiated: 2008-03-13
Posted by FDA: 2008-09-16
Terminated: 2008-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.