Stratafix Spiral recallZ-0150-2023 · Ethicon, Inc. · initiated Sep 20, 2022
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
FDA root cause category: Under Investigation by firm
What the company is doing
Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations
Recall details
- Recall number
- Z-0150-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 20, 2022
- Posted by the FDA
- Oct 31, 2022
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2,280 eaches
- Product code
- GAM
- FDA submissions
- K151200
- Distribution
- International distribution of the country of China.
Product description
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Code information (models, lots, serial numbers)
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Stratafix Spiral SXMD1B405Surgical Specialties México, S. de R.L. de C.V. · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall19 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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