—#202690

Product

Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000

FDA product code: LZN — Cement Obturator
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K931847
Affected lot / code info: GTIN: 04546540055422 Lot Numbers: 22306012 22307012 22340012 22341012 22342012 23017012

Why it was recalled

Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Stryker issued Urgent Medical Device Recall letter on 8/07/23. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement order will be shipped to customers upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. If you have any questions about this matter, contact Stryker Instruments by email at Instruments.Recalls@stryker.com.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK

Timeline

Recall initiated: 2023-08-07
Posted by FDA: 2023-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.