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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98342

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 12, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Waldemar Link GmbH & Co. KG (Mfg Site)

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

13 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 13

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Z-1511-2026
Recall number
Z-1511-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
44 units (1 US, 43 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 2 of 13

Endo-Model Replacement Plateau; Item Number: 15-0027/15;

Z-1512-2026
Recall number
Z-1512-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-0027/15; UDI-DI: 04026575432127; Serial/Lot Number: 2549190;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 3 of 13

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Z-1513-2026
Recall number
Z-1513-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
49 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 4 of 13

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Z-1514-2026
Recall number
Z-1514-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
31 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 5 of 13

Endo-Model Replacement Plateau; Item Number: 15-2835/12;

Z-1515-2026
Recall number
Z-1515-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
1 unit (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 6 of 13

Endo-Model Replacement Plateau; Item Number: 15-2836/11;

Z-1516-2026
Recall number
Z-1516-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
7 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 7 of 13

Endo-Model Replacement Plateau; Item Number: 15-8030/12;

Z-1517-2026
Recall number
Z-1517-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
4 units (all OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 8 of 13

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Z-1518-2026
Recall number
Z-1518-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
8 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 9 of 13

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Z-1519-2026
Recall number
Z-1519-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
7 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 10 of 13

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

Z-1520-2026
Recall number
Z-1520-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
4 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 11 of 13

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Z-1521-2026
Recall number
Z-1521-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
2 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 12 of 13

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

Z-1522-2026
Recall number
Z-1522-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
1 unit (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-0027/12; UDI-DI: 04026575431960; Serial/Lot Number: 2549036;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

device · product 13 of 13

Endo-Model Replacement Plateau; Item Number: 15-0027/16;

Z-1523-2026
Recall number
Z-1523-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
3 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Code information

Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;

Distribution pattern

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.