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Syneture Sofsilk 3/0 18" BLACK V-20 DT recallZ-2816-2011 · Covidien LP · initiated Jun 3, 2011

Terminated All recalls posted in July 2011

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 Covidien LP 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

Potential for the sterile barrier to be breached compromising the sterility of the product

FDA root cause category: Equipment maintenance

What the company is doing

Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at [email protected] or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.

Recall details

Recall number
Z-2816-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 3, 2011
Posted by the FDA
Jul 15, 2011
Recalling firm
Covidien LP
Quantity
31080 units
Product code
GAP
FDA submissions
K981128
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore

Product description

Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery

Code information (models, lots, serial numbers)

Lot Code Number:  D1C0080G D1C0251G D1C0272G D1C0454G D1C0455G D1C0492G D1C0493G D1C0719GX D1C0893GX D1C0894GX D1C0930GX D1C0934GX D1C1004GX D1D0057GX D1D0306GX

Other devices under the same FDA submission

117 devices cleared under K981128 — 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 59104).

Sources and updates

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