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00434811113, Ref I4348-111-13 recallZ-1092-2014 · Zimmer, Inc. · initiated Jan 10, 2014

Class II Terminated All recalls posted in February 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected] outside of the United States will occur approximately two weeks after the United States communications. For questions call 1-877-946-2761

Recall details

Recall number
Z-1092-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 10, 2014
Posted by the FDA
Feb 26, 2014
Recalling firm
Zimmer, Inc.
Quantity
10 units
Product code
KWT
FDA submissions
K041549
Distribution
Distribution USA in the state of Illinois.

Product description

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.

Code information (models, lots, serial numbers)

lot 62267250

Other devices under the same FDA submission

1 device cleared under K041549 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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