Hazard

Packaging Validation recalls

22 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 22
Critical: 0
Severe: 0
Most recent: 2014-02-26

Of the 22 packaging validation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all packaging validation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–22 of 22

ModerateFDA (Devices)·Z-1005-2014·2014-02-26
Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues
Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1003-2014·2014-02-26
Zimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues
Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1008-2014·2014-02-26
Zimmer Recalls Sterile Orthopedic Screws and Nails Due to Packaging Validation Issues
Zimmer is recalling specific sterile orthopedic screws and nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1018-2014·2014-02-26
Zimmer Recalls Modular Austin Moore Femoral Neck Implants Due to Packaging Validation
Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1032-2014·2014-02-26
Zimmer Recalls CPT 12/14 COCR Medical Devices Due to Packaging Validation Issues
Zimmer is recalling CPT 12/14 COCR devices because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
CPT 12/14 COCR (various sizes)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1033-2014·2014-02-26
Zimmer Recalls 6 Degree Femoral Heads Due to Packaging Validation Issues
Zimmer is recalling 6 Degree COCR Femoral Heads and 6 Degree Unipolar Femoral Heads because packaging operations at a Puerto Rico facility were not properly validated.
Product
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1015-2014·2014-02-26
Zimmer Recalls Orthopedic Implants Due to Packaging Validation Deficiencies
Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1007-2014·2014-02-26
Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues
Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1023-2014·2014-02-26
Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1021-2014·2014-02-26
Zimmer Recalls Knee Implant Components Due to Packaging Validation Issues
Zimmer is recalling specific knee implant components because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1013-2014·2014-02-26
Zimmer Recalls ITST Anti-Rotation Screws and Femoral Intramedullary Nails
Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.
Product
ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1016-2014·2014-02-26
Zimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations
Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1039-2014·2014-02-26
Zimmer Recalls Compression Screws Due to Packaging Validation Review
Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1020-2014·2014-02-26
Zimmer Recalls NEXGEN Osteotomy Cortical Bone Screws Due to Packaging Validation
Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1037-2014·2014-02-26
Zimmer Recalls FEM HD ION Hip Implants Due to Packaging Validation Issues
Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
FEM HD ION (various sizes)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1028-2014·2014-02-26
Zimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues
Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
VERSYS HERITAGE FEM STEM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1019-2014·2014-02-26
Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1035-2014·2014-02-26
Zimmer Recalls Modular Hip Implants Due to Packaging Validation Issues
Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.
Product
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1022-2014·2014-02-26
Zimmer Recalls NEXGEN Knee Implant Components Due to Packaging Validation Issues
Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1025-2014·2014-02-26
Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues
Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.
Product
HGP II ACETABULAR CUP BON
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1017-2014·2014-02-26
Zimmer Recalls Hip Prostheses Due to Packaging Validation Issues
Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1014-2014·2014-02-26
Zimmer Recalls One-Piece Lag Screws Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Category
Medical Device
Distribution
Distributed nationwide