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Terminated

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

FDA Recall Z-1336-2020 · Posted 2020-02-06

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeNEW
Date Initiated2019-08-28
Date Terminated2021-02-11
Product Quantity133 units

Reason for Recall

The product do not meet certain internal testing specifications.

Firm Action

On 8/28/2019, Ethicon contacted their international (OUS) customers and shared a copy of the Urgent Medical Device Recall notice issued to U.S. customers. Customers were advised to take the following actions: 1. Examine your inventory quarantine the recalled product 2. Do not open the foil pouches to conform contents 3. Complete the Business Reply Form (BRF)confirming receipt of this notice and fax or email it to Stericycle at 888-877-7241 or [email protected] within three (3) business days. 4. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. 5. Distributors are required to return unused subject to this recall that are in their inventory immediately. 6. To receive replacement product, customers must return product subject to this recall by November 30, 2019. Any non-affected product or impacted product returned after the date specified will not be replaced. If you require any assistance with returning product, please contact Stericycle at 888-759-6910 and reference Event# 5647. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.

Root Cause

Under Investigation by firm

Distribution Pattern

International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control DevicesETHICON, Inc. · 2019-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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