Facility

Heraeus Medical LLC

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

Key facts

2recalls · 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)	3013186738
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	Township Line Road 770, Suite 300 Yardley, PA, US 19067
Registration status	Active · expires 2026
Parent company	Heraeus Medical GmbH (owner-operator 10048423)
Brand names	COPAL exchange G hip spacer

Activity by year

Recalls (2)

Devices registered here (2)

Prosthesis, Hip, Hemi-, Femoral, Metal
Product code KWL (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3360
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product code KWY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3390

Recalls & enforcement

Class IIIOngoing2026-03-25
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Class IIOngoing2025-12-09
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If …

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. “Heraeus Medical LLC (FEI 3013186738) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013186738-heraeus-medical-llc/

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