—#202684

Product

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000

FDA product code: LZN — Cement Obturator
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K931847
Affected lot / code info: GTIN: 04546540055408 Lot Numbers: 22305012 22306012 22307012 22308012 22311012 22315012 22316012 22318012 22319012 22320012 22321012 22322012 22323012 22325012 22326012 22327012 22332012 22333012 22334012 22335012 22336012 22337012 22340012 22341012 22342012 22346012 22347012 22348012 22351012 22353012 22354012 22355012 22356012 22357012 22361012 22362012 22363012 22364012 23003012 23004012 23005012 23009012 23010012 23011012 23012012 23013012 23014012 23015012 23017012 23018012 23019012

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 #202684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.