—#129072

Product

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K960278
Affected lot / code info: Item Numbers : 00781804300, 00781805300, 00781804700, 00781805000, 00781804200, 00781805400, 00781804800, 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500 Lot Numbers: 37210958, 37210967, 37211180, 37211183, 37211311, 37211316, 37211320, 37211379, 37211482, 62561484, 37211643, 37211645, 37211646, 37211647, 37211653, 37211655, 37211657, 37211658, 37211661, 37211801, 37211804, 37211805, 37211806, 37211811, 37211812, 37211815, 37211817, 37211820, 37212062, 37212063, 37212065, 37212074, 37212079, 62573574, 62573576, 62576002, 62576008, 62593298, 62593302, 37212608, 37211644

Why it was recalled

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Root cause (FDA determination)

Package design/selection

Action the firm took

Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2014-07-22
Posted by FDA: 2014-08-26
Terminated: 2015-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.