00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revis

FDA device recall Z-2215-2012 · posted 2012-08-16 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KWA

Quantity affected

212 (179 USA)

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.

Date initiated

2012-07-18

Date posted

2012-08-16

Date terminated

2014-04-17

Location

Warsaw, IN

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