Facility

OPTIMIZED ORTHO PTY LTD

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

Key facts

8recalls · 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)	3012916784
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device
Location	17 Bridge Street Sydney New South Wales, AU 2073
Registration status	Active · expires 2026
Parent company	Corin Group (owner-operator 9012268)
Brand names	Surgical Instrument

Activity by year

Recalls (8)

Devices registered here (1)

Orthopedic Manual Surgical Instrument
Product code LXH (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2023-10-13
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Class IIOngoing2022-11-08
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Class IITerminated2022-10-31
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Class IIOngoing2022-07-22
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Class IITerminated2022-07-12
Some of the devices did not pass fatigue testing.
Class IITerminated2021-07-28
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Class IITerminated2021-05-06
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Class IITerminated2021-01-25
The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

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. “OPTIMIZED ORTHO PTY LTD (FEI 3012916784) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012916784-optimized-ortho-pty-ltd/

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