Recalls / —

—#169172

Product

HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

FDA product code

MQV — Filler, Bone Void, Calcium Compound

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K161447

Affected lot / code info

UDI - (01) 07613327064278 Lot Number: IC02595

Why it was recalled

Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

On November 15, 2018, Stryker issued Urgent Medical Device Recall notices to customers via Fedex. Customers were advised to take the following actions: 1. Inform users of the medical device recall and forward a copy of the notice to all those individuals who need to be aware within the organization. 2. Examine inventory to identify impacted HydroSet kits. 3. Immediately quarantine any affected product. 4. Complete and return the Business Reply Form via email to Strykerortho6629@stericycle.com or via fax to 1-888-345-3845. 5. Return all affected product available at your location to the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07431, Ref. PFA 1878253

Recalling firm

Firm

Howmedica Osteonics Corp.

Address

2 Pearl Ct, Allendale, New Jersey 07401-1611

Distribution

Distribution pattern

CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV

Timeline

Recall initiated

2018-11-15

Terminated

2020-06-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #169172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.