—#108781

Product

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K994366
Affected lot / code info: Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.

Why it was recalled

Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide distribution, including the states of NY, NJ, CA and FL.

Timeline

Recall initiated: 2012-10-23
Posted by FDA: 2013-01-08
Terminated: 2013-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.