ClearanceBrief
Recall Z-1417-06 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Zimmer Inc.

Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.

DateAug 26, 2006 (initiated Jul 20, 2006)
StatusTerminated
ReasonComponents may not lock together as intended.
Root causeOther
ActionConsignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
Quantity197 for all three recalls Z-1416-1418-06
DistributionWorldwide distribution --- USA and countries of Australia and China
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
Zimmer, Inc., Dec 19, 2005