—#87516

Product

DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers: 08150012, 08156012, 08179012, 08172012, 08221012, 08207012, 08247012, 08249012, 08302012, 08270012, 08310012, 08312012, 08354012, 09022012, and 08354012

Why it was recalled

Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: LA & MS

Timeline

Recall initiated: 2009-12-09
Posted by FDA: 2010-03-11
Terminated: 2010-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87516. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.