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PDS Plus Antibacterial (polydioxanone) Suture recallZ-1314-2009 · Ethicon, Inc. · initiated Feb 2, 2009

Terminated All recalls posted in May 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

FDA root cause category: Process control

What the company is doing

Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.

Recall details

Recall number
Z-1314-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 2, 2009
Posted by the FDA
May 12, 2009
Recalling firm
Ethicon, Inc.
Quantity
1,758,360 total
Product code
NEW
FDA submissions
K061037
Distribution
Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.

Product description

PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.

Code information (models, lots, serial numbers)

Lot number Expiration Date APM639 2010-07-31 12:00AM APM937 2010-07-31 12:00AM APZ507 2010-07-31 12:00AM APM952 2010-07-31 12:00AM APM660 2010-07-31 12:00AM APM651 2010-07-31 12:00AM APM726 2010-07-31 12:00AM APM599 2010-07-31 12:00AM

Other devices under the same FDA submission

50 devices cleared under K061037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51049).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page