FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 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
- Recall number
- Z-2816-2020
- Recalling firm
- Synthes (USA) Products LLC
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-07-21
- Posted
- not on file
- Terminated
- 2022-02-18
- Reason
- 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
- Root cause
- Process control
- Action
- 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: RA-DPYCH-flactionint@ITS.JNJ.com " 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: RA-DPYCH-flactionint@ITS.JNJ.com 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
- Quantity
- 191 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Number: 29P6036 UDI: 10886982166913
- 510(k) numbers
- ["K011335"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28