Reported Jul 22, 2020 · Terminated
ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids…
Skeletal Kinetics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skeletal Kinetics, Llc · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
- ACUMED IMPACT 5CC
- Product Number65-0105-S
- UDI813845020252 -
- Product UsageCallos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process
- Lot codes and dates
- Lot Numbers
112615011287901136332
- Lot Numbers
- Amount recalled
- 41
This recall covers 45 products
The agency filed one notice per product. You are reading one of them; the other 44 are below.
32 more are in the archive.
Where it was sold
Why it was recalled
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Skeletal Kinetics, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.