Facility

Industrias Apson S.A de C.V

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006509795
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	CALLE 15, # 780 Avenida 6-10 AGUA PRIETA Sonora, MX 84200
Registration status	Active · expires 2026
Parent company	Aspen Surgical Products (owner-operator 10061390)
Brand names	Symmetry Surgical

Activity by year

Recalls (4)

Devices registered here (1)

Splint, Extremity, Inflatable, External
Product code FZF (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.3900

Recalls & enforcement

Class IICompleted2024-06-03
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Class IITerminated2021-07-23
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the p…
Class IITerminated2014-03-20
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Class IITerminated2013-07-18
Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have b…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Industrias Apson S.A de C.V (FEI 3006509795) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006509795-industrias-apson-s-a-de-c-v/

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