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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Endo-Model SL Connection Components and Replacement Plateaus Recalled

Agency Publication Date: March 10, 2026
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Summary

Waldemar Link GmbH & Co. KG is recalling approximately 164 units of various Endo-Model SL Connection Components and Replacement Plateaus used in joint implants. The recall was initiated because a specific plateau screw bushing may detach from the screw shaft due to a longitudinal fracture. This defect can lead to the failure of the implant connection, potentially requiring additional medical intervention or revision surgery.

Risk

The bushing could detach from the screw shaft if it fractures lengthwise, which may cause the internal components of the joint replacement to fail or loosen. No specific injuries were mentioned in the recall data, but such a failure typically leads to joint instability and the need for corrective surgery.

What You Should Do

  1. Identify if you have any of the affected Endo-Model SL Connection Components or Replacement Plateaus by checking the Item Numbers, UDI-DI, and Serial/Lot Numbers on the product packaging. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Waldemar Link GmbH & Co. KG, or your distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Endo-Model SL Connection Component incl. PE-Plateau
Model / REF:
16-2840/05
Serial Numbers:
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
UDI:
04026575359240

Quantity: 44 units (1 US, 43 OUS)

Product: Endo-Model Replacement Plateau
Model / REF:
15-0027/15
Serial Numbers:
2549190
UDI:
04026575432127

Quantity: 3 units

Product: Endo-Model SL Connection Component incl. PE-Plateau
Model / REF:
16-2840/02
Serial Numbers:
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
UDI:
04026575359233

Quantity: 49 units (OUS only)

Product: Endo-Model SL Connection Component incl. PE-Plateau
Model / REF:
16-2840/07
Serial Numbers:
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
UDI:
04026575359257

Quantity: 31 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-2835/12
Serial Numbers:
241210/1809
UDI:
04026575316564

Quantity: 1 unit (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-2836/11
Serial Numbers:
250623/3643
250623/3644
250623/3645
250623/3646
250623/3648
250812/2812
250812/2811
UDI:
04026575316571

Quantity: 7 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-8030/12
Serial Numbers:
250721/0194
250721/0212
250721/0211
250721/0209
UDI:
04026575048151

Quantity: 4 units (all OUS)

Product: Endo-Model Replacement Plateau
Model / REF:
15-8521/09
Serial Numbers:
250728/0038
250728/0039
250728/0040
250728/0041
250728/0042
250728/0043
250728/0044
250728/0045
UDI:
04026575383238

Quantity: 8 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-8521/11
Serial Numbers:
250728/2220
250728/2222
250728/2223
250728/2224
250728/2225
250728/2226
250728/2227
UDI:
04026575383245

Quantity: 7 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-8521/15
Serial Numbers:
250805/0020
250805/0021
250805/0023
250805/0024
UDI:
04026575383283

Quantity: 4 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-0027/11
Serial Numbers:
2549126
2549127
UDI:
04026575431953

Quantity: 2 units (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-0027/12
Serial Numbers:
2549036
UDI:
04026575431960

Quantity: 1 unit (OUS only)

Product: Endo-Model Replacement Plateau
Model / REF:
15-0027/16
Serial Numbers:
2550412
2550413
2549228
UDI:
04026575432134

Quantity: 3 units (OUS only)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98342
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: surgical centers; hospitals; specialty medical distributors
Manufactured In: Germany
Units Affected: 13 products (44 units (1 US, 43 OUS); 3 units; 49 units (OUS only); 31 units (OUS only); 1 unit (OUS only); 7 units (OUS only); 4 units (all OUS); 8 units (OUS only); 7 units (OUS only); 4 units (OUS only); 2 units (OUS only); 1 unit (OUS only); 3 units (OUS only))
Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.