Recall events
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Event 99045
Event summary
Timeline bucket May 20, 2026
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Zimmer, Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
5 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Z-2527-2026
Recall number Z-2527-2026
Initiated May 20, 2026
Classification Class II
Status Ongoing
Quantity 474 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2527-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46804]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Code information Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[173]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Z-2528-2026
Recall number Z-2528-2026
Initiated May 20, 2026
Classification Class II
Status Ongoing
Quantity 435 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2528-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5308]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Code information Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[74]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Z-2529-2026
Recall number Z-2529-2026
Initiated May 20, 2026
Classification Class II
Status Ongoing
Quantity 429 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2529-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17111]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Code information Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[166]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Z-2530-2026
Recall number Z-2530-2026
Initiated May 20, 2026
Classification Class II
Status Ongoing
Quantity 11 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2530-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5930]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Code information Lot Code: 110040444 ; UDI-DI (01)00889024681903(17)350531(10)097487 ; Lot Number 097487
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[161]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Z-2531-2026
Recall number Z-2531-2026
Initiated May 20, 2026
Classification Class II
Status Ongoing
Quantity 13 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2531-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5307]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Code information Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492
Distribution pattern US Nationwide distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[111]
FDA event record
· Exact recall-number query on openFDA
