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LCP recallZ-2816-2020 · Synthes (USA) Products LLC · initiated Jul 21, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw

FDA root cause category: Process control

What the company is doing

DePuy Synthes issued Urgent Medical Device Removal letter dated July 21, 2020 stating reason for recall, health risk and action to take: Please take the following actions: 1. Immediately examine your inventory to determine if you have product subject to this action on hand and quarantine the subject product. 2. Complete the attached Verification Section (page 3 of this letter). Please include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. If you have product to be returned: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Return the completed Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 " Send a copy of the completed Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: [email protected] " Return any subject product within 10 business days. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: [email protected] 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until the product subject to this action has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. Questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant

Recall details

Recall number
Z-2816-2020
Status
Terminated
Initiated by the company
Jul 21, 2020
Recalling firm
Synthes (USA) Products LLC
Quantity
191 units
Product code
HRS
FDA submissions
K011335
Distribution
US Nationwide distribution.

Product description

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381

Code information (models, lots, serial numbers)

Lot Number: 29P6036 UDI: 10886982166913

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

10 devices cleared under K011335 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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