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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle

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  Class 2 Device Recall Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle see related information
Date Initiated by Firm July 18, 2012
Date Posted August 16, 2012
Recall Status1 Terminated 3 on April 17, 2014
Recall Number Z-2213-2012
Recall Event ID 62540
510(K)Number K060704  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWA
Product 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle
Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
Code Information Part 00-4309-028-01: Lot 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60842967, 60739623, 60896979, 60936815, 61019785, 61051017
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Jaime L. Weeks
574-371-1689
Manufacturer Reason
for Recall		 Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain
FDA Determined
Cause 2		 Device Design
Action Zimmmer sent an Urgent Medical Device Recall letter dated July 18, 2012, to all affected customers. The letter identified the product, the problem, and thea action to be taken by the customer. Customers were instructed to inspect all TM Reverse instrument sets for affected lot(s)(instruments. If affected product was found customers were instructed to immediately place an order to backfill the identified product with Customer Service. If an instrument was was further distributed customers were to provide a copy of the Notice to ensure their customers were aware of the removal. Customers were also instructed to provide a list of all hospitals that currently use the affected product. For questions customers were instructed to call 800-348-2759. For questions regarding this recall call 574-371-1689.
Quantity in Commerce 252 (210 in USA)
Distribution Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = ZIMMER, INC.
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