—#129069

Product

Endo & Unipolar Femoral Heads: 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 ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K955473
Affected lot / code info: Item Numbers 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01

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 #129069. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.