NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be impla

FDA device recall Z-2086-2014 · posted 2014-07-21 · Terminated

Recall details

Recalling firm

Exactech, Inc.

Reason for recall

The femoral stem is lacking specified plasma coating.

Action taken

Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Determine if they have any of the affected devices " Fax back the attached form. Complete the attached fax back form and return it to Exactech. Customers were instructed to contact their Exactech inventory representative within 5 business days to confirm quantities at their location. For any inventory restocking questions related to this issue, please call 1-800-392-2832. For questions regarding this recall call 800-392-2832.

Root cause

Component design/selection

Status

Terminated

Product code

LZO

Quantity affected

10

Distribution

Worldwide Distribution including Spain, Greece and Japan

Date initiated

2014-03-07

Date posted

2014-07-21

Date terminated

2014-08-04

Location

Gainesville, FL

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