Z-2816-2020Class II

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm -

Name: Z-2816-2020 DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm -
Creator: Synthes (USA) Products LLC
Published: 2020-07-21
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2020-07-21 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2020-07-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2816-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-21
Posted: 2020-08-17
Terminated: 2022-02-18
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: manufacturing process
FDA 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: [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
Quantity in commerce: 191 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: 29P6036 UDI: 10886982166913

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2816-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2816-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-17

Product code HRS

K011335Class IISynths One-Third Tubular Dcl PlateSynthes (Usa) / cleared 2001-07-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)