Modular Hybrid Glenoid

• • Terminated Z-2216-2017 FDA Class II ·initiated 26 Apr 2017

  Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.

• • Terminated Z-1859-2017 FDA Class II ·initiated 17 Feb 2017

  Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

• • Terminated Z-1658-2008 FDA Unclassified (pre-2012) ·initiated 13 Mar 2008 ·on shared 510(k) K060694

  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

• • Terminated Z-0660-2013 FDA Class II ·initiated 6 Dec 12

  Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K060694 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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