MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
FDA Device Recall #Z-1035-2014 — Class II — October 11, 2013
Recall Summary
| Recall Number | Z-1035-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 11, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 7,044,680 total |
Product Description
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Reason for Recall
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Lot / Code Information
60169597 365445 60096116 60096117 60134409 60845244 61059560 61613250 366221 60096118 60553617 60743729 60990038 61298521 365622 60096119 60411949 60501830 60540531 60609946 60700469 61657255 365458 60110443 60154855 60187556 60301871 60484369 60590160 60716272 60768572 60887301 61118584 61211680 61304669 61589078 61619986 366386 60096121 60124827 60169413 60242838 60301886 60411970 60484390 60540735 60565849 60610009 61122126 61401537 61694181 61878452 61934378 61992515 365461 366387 367572 60109037 60110290 60124913 60169470 60204787 60242845 60326542 60395275 60423101 60474918 60484409 60768593 60845456 61199171 61298517 61613251 61817985 61992516 365499 367548 369841 60096125 60110448 60148883 60242895 60293315 60484704 60540826 60581312 60737211 61103540 61324218 61619209 61659604 61758278 61817987 366388 369882 60109039 60124924 60134410 60169479 60187599 60242901 60293321 60335415 60442118 60506747 60993378 60993379 61118585 61276626 61398796 61651794 61756168 61758280 60096126 60187653 60412010 60537009 60574597 60787916 61118586 61932403 366389 369842 60124934 60187682 60274760 60423134 60980807 61231910 61651793 61837093 365464 365604 60096127 60355236 60540889 60565935 61662668 61976171 365444 60085816 60148884 60484813 61042186 61290074 61528630 61744433 60301911 60541000 61059561 61555631 61658313 366382 60154916 60395295 60900095 61324217 60096128 60541001 61370524 365448 60096186 60553915 61496597 60096187 60096188 366307 60096189 60096190 60166763 367542 60110458 60301876 60906529 60169412 60326978 60484392 61895487 60099418 60242846 60506729 60096192 60096193 365496 60523403 60331362 365481 366300 61222214 365500 60906530 61886563 366301 60096195 60484817 61886564 365449 366304 60423158 60906531 60096202 60331367 365616 366578 367657 369317 60101998 60101999 60113196 60113197 60145797 60156493 60178358 60187897 60213589 60274027 60284125 60284126 60294382 60313728 60382721 60411695 60467652 60474624 60614956 60708479 60793758 60822078 60822089 60876798 60899020 61092517 61104296 61172285 61199985 61243392 61282926 61293847 61336987 61435528 61555658 61664257 61696348 369400 60102000 60102001 60113198 60135105 60135108 60156495 60156496 60178359 60187902 60213591 60222247 60234255 60273998 60275695 60294383 60313730 60313732 60324334 60345750 60382722 60411698 60457745 60474626 60535059 60551516 60589262 60708480 60793770 60822079 60822090 60876799 60899021 61092518 61172276 61172277 61199987 61263822 61282922 61293846 61337003 61435527 61460812 61522994 61550878 61555659 61696349 365615 365617 369401 60145802 60187905 60324336 60429016 60474628 60474629 60803409 61115345 61351331
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0981-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0973-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0977-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0967-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.