—#124348

Product

Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130661
Affected lot / code info: Part 00-4349-036-11, Lot 62393502

Why it was recalled

Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Zimmer sent an Urgent Medical Device Recall letter dated December 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. If affected product was found, it should be quarantines and their Zimmer representative notified. The Zimmer sales representative will remove the recalled product from their facility. Customers with questions were instructed to call 1-877-946-2761. .

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.

Timeline

Recall initiated: 2013-12-10
Posted by FDA: 2013-12-30
Terminated: 2014-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124348. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.