Facility

ENZTEC LIMITED

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

Key facts

1recalls · 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)	3004641308
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	3/17 PRINT PLACE, MIDDLETON CHRISTCHURCH Canterbury, NZ 8024
Registration status	Active · expires 2026
Parent company	ENZTEC LIMITED (owner-operator 9084846)

Activity by year

Recalls (1)

Devices registered here (1)

Guide, Surgical, Instrument
Product code FZX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IITerminated2019-08-16
The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision…

All facilities operated by ENZTEC LIMITED

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. “ENZTEC LIMITED (FEI 3004641308) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004641308-enztec-limited/

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