Stratafix Spiral recallZ-1053-2022 · Ethicon, Inc. · initiated Mar 24, 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
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
FDA root cause category: Employee error
What the company is doing
A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.
Recall details
- Recall number
- Z-1053-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 24, 2022
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2808 (all OUS)
- Product code
- GAM
- FDA submissions
- K122898
- Distribution
- International distribution in the country of China.
Product description
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Code information (models, lots, serial numbers)
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Stratafix Spiral SXMD1B403Surgical Specialties México, S. de R.L. de C.V. · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall2 reports
- Stratafix Spiral SXMD1B100Surgical Specialties México, S. de R.L. de C.V. · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall1 report
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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