Recalls · Brand

Kelyniam Global, Inc. recalls

Every recall we track for Kelyniam Global, Inc. — 4 in all, all from 2017 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.

4recalls

Recalls per year, by danger level

Recalls from Kelyniam Global, Inc. peaked in 2017 (4); 4 since 2017.

All FDA recall records for Kelyniam Global, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Kelyniam Global, Inc., by danger level
Year	Stop using now	Not yet rated	Total
2017	1	3	4
2018	0	0	0
2019	0	0	0
2020	0	0	0
2021	0	0	0
2022	0	0	0
2023	0	0	0
2024	0	0	0
2025	0	0	0
2026 (to date)	0	0	0

What to do if you have a recalled Kelyniam Global, Inc. product

Match the model, catalog or lot number on your device to the recall.
Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
Report problems to FDA MedWatch.

See this week’s new recalls.

All Kelyniam Global, Inc. recalls

1 shown

UnratedMedical device
Kelyniam Global, Inc. recalls Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Kelyniam recalls Custom Skull Implant (CSI) Model PEEK-IM1003 with unvalidated design changes that may cause injury. Affected units include specific case numbers and revisions up to rev. A.
KelyniamJun 10, 2017

Kelyniam Global, Inc. recall questions

How many recalls has Kelyniam Global, Inc. had?

4 recalls from Kelyniam Global, Inc. are on record with U.S. safety agencies, from 2017.

What is the most recent Kelyniam Global, Inc. recall?

Kelyniam Global, Inc. recalls Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003, dated Jun 10, 2017. Every Kelyniam Global, Inc. recall is listed on this page, newest first.

What should I do if I have a recalled Kelyniam Global, Inc. product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Kelyniam Global, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.