—#124650

Product

00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041549
Affected lot / code info: lot 62267250

Why it was recalled

This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Zimmer sent an Urgent Medical Device Recall dated January 10, 2014 to distributors via electronic mail. The hospital/surgeon that has implanted this manufacturing lot will be identified and notified by the distributor. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to locate and remove the affected product in their territory, as well as identifying and notifying the hospital/surgeon that has implanted this manufacturing lot as applicable. The distributor will return on-hand affected products to Zimmer and ensure all of their products are accounted for using the return form provided in the letter. Distributors and hospital consignees are to complete and return the inventory return form and acknowledgement form indicating which hospital/surgeon has implanted the product and to which they have provided notice to. Email a copy of the completed return form to CorporateQuality.PostMarket@Zimmer.comCommunications outside of the United States will occur approximately two weeks after the United States communications. For questions call 1-877-946-2761

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Distribution USA in the state of Illinois.

Timeline

Recall initiated: 2014-01-10
Posted by FDA: 2014-02-26
Terminated: 2014-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.